Enhancing Clinical Trial Monitoring: Ensuring Data Integrity and Research Participant Well-Being

Clinical trial monitoring is a cornerstone of ensuring the safety and welfare of research participants, as well as maintaining the integrity of clinical trial data. This essential process involves overseeing the progress of a clinical trial to ensure it is conducted, recorded, and reported in accordance with the study protocol, applicable Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), international and national standards (such as ISO or HRSO) and other regulatory requirements. Monitoring can be conducted on-site or remotely, depending on various considerations.

Adopting a robust monitoring strategy is crucial for sponsors and Contract Research Organizations (CROs) to effectively protect research participants’ safety and well-being while fostering research integrity throughout the study’s lifecycle.

In medical aesthetics, adopting a sound monitoring strategy based on a comprehensive risk assessment is particularly important due to the wide range of treatment options available. These options include medical devices (such as energy-based devices and dermal fillers), topical or injectable drugs, biologicals, cosmeceuticals, and natural health products.

A thorough risk assessment helps ensure that the monitoring strategy is tailored to the specific risks of the study, thereby enhancing research participant safety and data integrity.

In this blog post, you will learn about the purpose of monitoring, the various forms of monitoring strategies, and the importance of risk management in developing a monitoring plan for your clinical trial. By the end of this post, you will have a comprehensive understanding of the critical role monitoring plays in clinical trials, including how to enhance oversight and management through innovative approaches and advanced data visualization techniques.

What is Clinical Trial Monitoring?

Clinical trial monitoring involves the continuous oversight of a clinical trial’s progress to ensure adherence to the study protocol, SOPs, GCP, and relevant regulatory requirements.

The main objectives of trial monitoring are to confirm that:

  1. The rights and well-being of research participants are protected.
  1. The reported trial data are accurate, complete, and verifiable from source documents.
  2. The conduct of the trial is in compliance with the currently approved protocol/amendment(s), good clinical practices for drug trials or international standards for medical device trials, and applicable regulatory requirements.

In essence, the objective of clinical trial monitoring is to promptly identify and manage any negative impacts of research. Negative impact refers to any event, whether anticipated or not, that does or could adversely affect research data integrity, the health, welfare, interests, or rights of research participants, investigators/researchers, and third parties such as families and communities, or the conduct of the research. The nature of the negative impact may be social, behavioral, psychological, physical, or economic. Examples include, but are not limited to, breaches of privacy, incidental findings, adverse events, serious adverse events, non-compliance, and unanticipated problems.

What are the Various Monitoring Strategies?

To achieve its objectives, clinical trial monitoring employs a variety of strategies. The adoption of these strategies depends on multiple factors and requires proper planning. One of the primary strategies is on-site monitoring.

On-site Monitoring

On-site monitoring involves an in-person evaluation carried out by personnel from the sponsor or its Contract Research Organization (CRO) at the sites where the clinical investigation is being conducted. This method allows for direct interaction with the investigative site staff, providing a hands-on approach to monitoring.

Trained personnel visit the research site to evaluate trial procedures, ensure compliance with protocols and regulations, and verify data accuracy. This approach is crucial for protecting research participant safety and maintaining data integrity.

On-site monitoring is essential for ensuring data integrity and accuracy. One key activity is Source Data Verification (SDV), which involves comparing data entered in case report forms (CRFs) to the source documents, such as medical records, to ensure accuracy. Another important task is the review of source documents, where research participant records, consent forms, and other relevant documents are examined to verify compliance and accuracy.

Additionally, on-site monitoring includes evaluating the site’s training and performance. This involves assessing the site staff’s understanding of the protocol, procedures, and regulatory requirements to ensure they are knowledgeable and capable of conducting the trial effectively. Site performance assessment evaluates the site’s ability to conduct the trial efficiently and effectively. The review of study drug accountability ensures proper handling, storage, and dispensing of study drugs.

Research participant safety is another critical aspect of on-site monitoring. Verification of participant enrollment ensures that participants meet the eligibility criteria and that enrollment procedures are followed correctly. Adverse event reporting involves confirming that all adverse events are appropriately reported within the required timeframes, ensuring participant safety throughout the trial.

Advantages of On-site Monitoring

On-site monitoring offers several benefits. Direct interaction with site staff allows for immediate resolution of issues and clarification of procedures. The physical presence at the site enables a thorough review of source documents and verification of data accuracy. Additionally, it enhances the ability to assess the site’s compliance with protocols and regulatory requirements. Improved communication and relationship-building with site staff foster collaboration and trust.

Limitations of On-site Monitoring

Despite its advantages, on-site monitoring has some limitations. Higher costs are associated with travel, accommodation, and personnel time. The limited frequency of visits may result in delayed identification and resolution of issues. There is also the potential for disruption to site operations during monitoring visits. Effective monitoring depends on the availability and cooperation of site staff. Additionally, Source Data Verification (SDV) as a quality control measure in clinical trials is a source of debate, with some experts questioning its effectiveness and efficiency​.

Remote Monitoring

Remote monitoring is the process of virtually overseeing clinical trial data from a remote location using digital trial technology. This approach offers the advantage of real-time data access and analysis, enabling timely identification and resolution of issues. It is particularly useful in situations where on-site visits are not feasible or practical.

Remote monitoring involves conducting monitoring activities from a distance, without visiting the trial site. Monitors can review documents, data, and reports through digital platforms and applications. Tasks such as source document verification, data review, and query resolution can be performed via email or secure online systems.

Advantages of Remote Monitoring

Remote monitoring offers several benefits. It is cost and time efficient, reducing travel expenses and allowing for more frequent checks, making the monitoring process more flexible and efficient. Monitors can access and analyze data in real-time, enabling timely identification and resolution of issues. Additionally, remote monitoring can be conducted from any location, making it a practical solution when on-site visits are not feasible.

Limitations of Remote Monitoring

Despite its advantages, remote monitoring also comes with several limitations. Ensuring the accuracy and completeness of data collected remotely can be challenging, as monitors may find it difficult to verify data without direct access to source documents. Remote monitoring relies heavily on digital tools and platforms, and any technical issues, such as software malfunctions or connectivity problems, can disrupt the monitoring process. The lack of face-to-face interaction can hinder effective communication and relationship-building between monitors and site staff, impacting the resolution of issues and the overall quality of the trial. Additionally, protecting research participant data and maintaining confidentiality is crucial, and remote monitoring systems must have robust security measures to prevent data breaches.

Hybrid Monitoring

Hybrid monitoring combines on-site and remote approaches to enhance the oversight of clinical trials. By integrating the strengths of both methods, hybrid monitoring provides a balanced and thorough evaluation of trial progress, ensuring that both local and broader perspectives are considered. This approach leverages the strengths of traditional on-site monitoring and remote monitoring to optimize trial oversight and data quality.

Hybrid monitoring combines on-site and remote approaches to enhance the oversight of clinical trials. Here are some key aspects:

  • On-Site Visits: Certain critical activities, such as initial site setup, training, and complex assessments, are conducted in person at the trial site. This allows for direct interaction with site staff and hands-on evaluation.
  • Remote Monitoring: Routine data checks, document reviews, and follow-up activities are performed remotely using digital tools and platforms. This enables real-time data access and analysis.
  • Risk-Based Approach: This approach focuses on high-risk areas identified through centralized data analysis, allowing for targeted on-site visits and efficient resource allocation. It ensures that monitoring efforts are concentrated where they are most needed.

Advantages of Hybrid Monitoring

Hybrid monitoring offers several benefits. It provides flexibility by allowing for a more adaptable monitoring schedule, reducing the need for frequent travel and enabling timely interventions. This flexibility is particularly beneficial in complex trials or those involving multiple sites. Hybrid monitoring is also cost-effective, as it reduces overall monitoring costs by minimizing travel expenses and optimizing resource use, making it a practical and economical choice. Additionally, it enhances data quality by combining real-time remote data analysis with periodic on-site verification, ensuring comprehensive oversight. This dual approach helps maintain high standards of data integrity and participant safety.

Centralized Monitoring

Centralized monitoring involves reviewing research participant data from multiple investigational sites or across research participant populations at a remote, central location. This type of monitoring is conducted by sponsor or CRO personnel, such as data management personnel or statisticians. It allows for a comprehensive analysis of data, helping to identify trends and potential issues across different sites. This approach provides additional monitoring capabilities that complement and reduce the extent and frequency of on-site monitoring, helping to distinguish between reliable and potentially unreliable data.

Centralized monitoring involves the review of accumulating data through statistical analyses, which can be used to:

  • Identify Missing Data: Detect gaps in the collected data to ensure completeness.
  • Spot Inconsistent Data: Recognize discrepancies in the data to maintain accuracy.
  • Detect Data Outliers: Identify unusual data points that may indicate errors or anomalies.
  • Identify Unexpected Lack of Variability: Observe uniformity in data that may suggest issues with data collection.
  • Monitor Protocol Deviations: Ensure adherence to the study protocol and identify any deviations.
  • Examine Data Trends: Analyze the range, consistency, and variability of data within and across sites to identify patterns.
  • Evaluate Systematic or Significant Errors: Assess errors in data collection and reporting at a site or across sites, or potential data manipulation or data integrity problems.
  • Analyze Site Characteristics and Performance Metrics: Evaluate the performance of investigational sites to ensure effective trial conduct.
  • Select Sites for Targeted On-Site Monitoring: Use data analysis to identify sites or processes that require focused on-site monitoring.

Centralized monitoring offers a comprehensive and efficient approach to overseeing clinical trials, ensuring data integrity and research participant safety while optimizing resource use.

How to Develop the Right Monitoring Strategy for Your Clinical Trial

During the proposal process or at the outset of clinical study planning, the CRO and the sponsor should discuss and agree on the monitoring strategy. This strategy may include on-site and/or remote monitoring, tailored to the specific needs and risks of the trial. It should address the research participant protection and data integrity risks associated with the trial.

ethica CRO uses a Monitoring Risk Calculator to determine the recommended monitoring strategy. This tool provides fact-based results to calculate the overall risk score for monitoring. The calculation is based on information available during the proposal phase (such as the protocol synopsis) and considers applicable criteria.

According to the results of the ethica CRO Monitoring Risk Calculator and its decision table, the clinical study monitoring strategy will be classified into one of three categories:

  • Low-risk: Minimal monitoring, routine safety checks, primarily utilizing remote monitoring methods.
  • Medium-risk: Regular monitoring with periodic site visits and data reviews, incorporating a combination of on-site and remote monitoring.
  • High-risk: Intensive monitoring with frequent site visits, real-time data collection, and comprehensive safety reviews, employing hybrid monitoring and centralized monitoring approaches.

The final monitoring strategy, including the rationale for its determination, will be described in the study-specific monitoring plan. Note that the monitoring strategy may be adjusted throughout the life cycle of the clinical trial as additional information becomes available (e.g., new study risks identified, protocol amendments, etc.).

Risk Assessment

Based on the level of risk identified, study needs, and budget, ethica CRO will recommend a monitoring strategy to the sponsor. To finalize the monitoring strategy, ethica CRO and the sponsor will work together to adapt it as applicable, ensuring adequate monitoring for the level of risk identified. For instance, if the sponsor requests fewer on-site visits for a medium-risk study, the monitoring strategy could provide more remote oversight and increased communication with sites.

Criteria for Determination of Monitoring Scope, Frequency, and Extent

Determining the scope, frequency, and extent of monitoring human research involves a thorough assessment of various criteria. These criteria help ensure that the monitoring strategy is tailored to the specific needs and risks of the clinical trial.

The criteria include, but are not limited to:

Human Research Project Characteristics
  • Design Complexity: The complexity of the study design can impact the level of monitoring required. More intricate designs may necessitate more frequent and detailed monitoring.
  • Duration of the Research: Longer studies may require ongoing monitoring to ensure continued compliance and data integrity.
  • Research Population’s Characteristics: The demographics and health status of the research population can significantly influence monitoring needs. Vulnerable populations, such as children or individuals experiencing cognitive decline, may require more intensive oversight to ensure their protection and the integrity of the data collected.
  • Complexities Related to Informed Consent: Challenges in obtaining informed consent can necessitate additional monitoring to ensure ethical standards are met.
  • Type of Research: Different types of research (such as interventional vs observational studies) may have varying monitoring requirements.
  • Type(s) and Methods of Research Data Collected: The nature of the data collected (such as participant-reported outcomes, questionnaires, photography, imaging, wearable devices) can affect monitoring strategies.
  • Therapeutic or Care Area: The specific therapeutic or care area being studied can influence monitoring needs.
  • Type of Intervention: The intervention being studied (such as drugs, devices, cosmeceuticals) can impact the extent of monitoring required.
  • Current Regulatory Status of Intervention: The regulatory status of the intervention and potential changes during the research can affect monitoring strategies.
  • Development Phase: The phase of clinical research can determine the level of monitoring needed.
  • Regulatory Governance Framework: The regulatory framework governing the research can influence monitoring requirements.
  • Complexity of Laboratory Analyses: The complexity of laboratory analyses, including the collection, storage, and processing of biological materials, can impact monitoring needs.
  • Sensitive Identifiable Information: Studies involving the collection, use, and conservation of sensitive identifiable information require careful monitoring to ensure data privacy and security.
  • Controlled Substances: Research involving the use of controlled substances necessitates stringent monitoring to comply with regulatory requirements.
  • Dangerous Goods: Studies involving the use of dangerous goods require additional oversight to ensure safety and compliance.
Risk of Negative Impacts
  • Studies That May Result in Serious Adverse Events: Research with a higher risk of serious adverse events may require more intensive monitoring.
  • Studies Intended to Provide Definitive Information About Effectiveness and/or Safety: Trials aimed at determining the effectiveness and safety of interventions may necessitate rigorous monitoring.
  • Studies with Multiple Research Sites: Multi-site studies require timely data sharing and coordination among investigators, necessitating robust monitoring.
  • Controlled Studies with Mortality or Major Morbidity Endpoints: Studies with critical endpoints like mortality or major morbidity may benefit from statistical comparisons among treatment groups to assess risks.
  • Studies Where Early Termination is Ethically Important: Trials that may need to be stopped early if primary questions are definitively answered require careful monitoring to ensure ethical standards.
Investigators/Researchers and the Research Site
  • Qualifications and Training: The qualifications and training of investigators and researchers can impact the level of monitoring required.
  • Experience with the Type of Research: Investigators’ experience with the specific type of research being conducted can influence monitoring needs.
  • Experience with the Type of Intervention: Experience with the intervention being studied can affect the extent of monitoring required.
  • Experience with the Research Population: Familiarity with the varied characteristics of the research population can impact monitoring strategies.
  • Competing Research Projects: The presence of or potential for other competing research projects can affect the time commitment for the research project and the ability to recruit participants.
  • Recruitment Targets: The ability to meet participant recruitment targets can impact monitoring strategies.
  • Compliance Concerns: Any compliance concerns with the investigators, researchers, or research site can necessitate additional monitoring.

By considering these criteria, sponsors and CROs can develop a monitoring strategy that is well-suited to the specific characteristics and risks of the clinical trial. This tailored approach helps ensure the protection of human subjects and the integrity of the trial data.

Monitoring Plan

Once the monitoring strategy is established, ethica CRO will develop a detailed monitoring plan. This plan will outline the monitoring strategy, the responsibilities of all parties involved, the various monitoring methods to be used, and the rationale for their use. Emphasis will be placed on monitoring critical data and processes, particularly those aspects that are not routine clinical practice and require additional training. The monitoring plan will reference applicable policies and procedures to ensure compliance.

The monitoring plan for a research study must include a rationale for both the extent and choice of monitoring methods, whether on-site, centralized/remote, or a combination of both. All monitoring activities in a clinical study will be conducted according to the study-specific monitoring plan.

Enhanced Centralized Monitoring using Clinical Data Visualization Dashboards

ethica CRO has significantly enhanced centralized monitoring in clinical trials with its innovative clinical data visualization dashboards. These dashboards are designed to monitor ongoing clinical trials, ensuring a consistent approach and adherence to ethica CRO’s Human Research Protection Program (HRPP).

Serving as study-specific tracking tools for key performance indicators (KPIs) and other progress metrics, the dashboards integrate sophisticated data technology for continuous analysis. This allows for the quick identification of trends, anomalies, and risks across multiple sites, providing stakeholders with timely, actionable data crucial for effective decision-making.

By combining the strengths of both remote and on-site monitoring, this hybrid approach optimizes resource use and reduces overall monitoring costs. Leveraging these advanced tools, ethica CRO enhances the ability to maintain high data quality and regulatory compliance, ultimately contributing to the success and integrity of clinical trials.

Moreover, ethica CRO’s dashboards uniquely support centralized monitoring by offering a robust, secure, and efficient system for tracking and analyzing clinical trial data. This system ensures a consistent monitoring approach, allowing all aspects of the trial to be closely observed and managed. The real-time insights provided by the dashboards enable stakeholders to quickly identify and address any issues, ensuring the trial progresses smoothly and successfully.

By leveraging these advanced clinical data visualization dashboards, ethica CRO enhances the overall monitoring strategy, providing a comprehensive and reliable method for overseeing clinical trials. This innovative approach not only improves the efficiency of centralized monitoring but also ensures the protection of research participants and the integrity of trial data.

Conclusion

In conclusion, effectively monitoring medical aesthetics clinical trial progress and addressing emerging issues is crucial to protect research participants and ensure the integrity of the study. By understanding the fundamentals of clinical trial monitoring, exploring various monitoring strategies, and developing a tailored approach for your specific trial, you can enhance the oversight and management of your research. Leveraging advanced clinical data visualization dashboards for centralized monitoring provides valuable real-time insights and facilitates timely interventions. Implementing these strategies will not only improve the quality of your clinical trial but also contribute to the advancement of medical aesthetics research. By integrating technology and adopting a hybrid approach that combines remote and on-site monitoring, you can optimize resource use, reduce overall monitoring costs, and maintain high data quality and regulatory compliance. Ultimately, these efforts will lead to successful and reliable clinical trials, driving progress in the field of medical aesthetics.

If you’re ready to take your clinical trial monitoring to the next level, consider partnering with ethica CRO. Our innovative solutions and expert team are here to support you every step of the way. Contact us today to learn more about how we can help you achieve your research goals and ensure the success of your clinical trials.

Medical Aesthetics Industry: Trends Shaping a Growing Market

Medical Aesthetics Market Potential: Industry Trends Shaping the Future

Aesthetic medicine is a field that is experiencing steady growth worldwide. A significant driver for this thriving market is the rising societal focus on individual appearance, which is propelling an increased desire for aesthetic products, devices and procedures.

This growing demand is reshaping the healthcare landscape, as more and more medical practitioners, regardless of their specialties, engage in medical aesthetic practices. Producers of medical devices and products are also facing ever higher demands for their inventions.

The aesthetic medicine market is expected to continue to flourish, driven by factors such as increasing consumer awareness, technological advancements, increasingly diverse populations, and advancements in technology.

Top 6 industry trends in medical aesthetics

The growing medical aesthetics industry is currently characterized by six main trends. Factors affecting this field are many and diverse, however several developments currently have the largest impact on this booming industry:

1. Accessibility of aesthetic procedures and products

There is a growing demand for aesthetic medicine treatments around the world. The global aesthetic medicine market was valued at $82.46 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 8.3% from 2024 to 2030. This indicates a strong and increasing demand for aesthetic treatments on every continent.

In response to this demand, an increasing number of healthcare professionals are being authorized by state and provincial professional regulatory bodies to perform cosmetic procedures. This trend is not limited to board-certified dermatologists but includes a variety of healthcare practitioners, such as general physicians, nurses, and even dentists. The proliferation of med spas and the widespread use of medical aesthetics products have made these treatments more accessible than ever. However, this accessibility brings new ethical considerations that must be addressed to ensure patient safety and uphold the integrity of the healthcare professions. One of the most critical aspects is ensuring patients’ informed consent and informed choice. Patients must be fully aware of the risks, benefits, and potential outcomes of the procedures they are considering. Clear communication and thorough consultations are essential to help patients make well-informed decisions that align with their expectations and health needs. 

Governments, professional bodies and manufacturers must coordinate efforts to implement effective regulation of procedures, devices and products, and enforce recognition of patients’ rights in both clinical and trial settings.

2. Diversity of populations

The aesthetic medicine market has seen a significant expansion and diversification of consumer segments. For example, between 2000 and 2018, there was a 29% increase in males undergoing cosmetic procedures overall, with a 72% increase in minimally invasive procedures for this group.

In addition, the demand for aesthetic treatments is not limited to a single region. Countries like India and South Korea are seeing increased interest in procedures such as liposuction, nose reshaping, and botulinum toxin injections. India, for instance, was ranked among the top 5 countries performing non-surgical procedures globally in 2022. This evidence indicates that it is more important than ever that aesthetic medicine clinical trials be performed with respect to this diversity, and that the active participation of research participants from diverse genetic backgrounds is imperative to conducting ethical and effective trials. 

3. Ease and comfort of procedures

Another trend affecting the aesthetic medicine industry is the prioritization of the simplicity and comfort of procedures. Users are drawn to treatments that are comparatively easy to perform and offer a low-impact experience.

  1. Minimally invasive procedures: There is a growing preference for treatments with minimal downtime that use less invasive techniques. This includes procedures like mini facelifts, micro-liposuction, and non-surgical skin tightening treatments. Minimally invasive and non-invasive techniques typically offer more comfort and less downtime than their surgical alternatives.
  1. Combination procedures: Patients are opting for combined treatments that address multiple concerns in a single session, as these save time and reduce overall costs. This approach allows for a more holistic and efficient treatment experience.
  1. Focus on natural results: The trend towards enhancing natural beauty rather than dramatic transformations is driving the development of more subtle, comfortable procedures that don’t require extensive recovery periods.

4. At-home use of devices and products

A market report published in 2022 revealed that 81 percent of consumers are more accepting of noninvasive aesthetic treatments than they were five years ago. This shift in attitudes contributes to the growing demand for the types of products and treatments that can be used at home.

The most important ethical consideration related to this trend is the education of users, who need to be fully informed about the potential risks and consequences of self-administering cosmetic treatments, even those that are noninvasive.

Realistic expectations, both in terms of user well-being and the tangible results of a treatment, must be communicated for all products and devices available to the public, including hair removal technology, topical formulations and light and laser therapy for hair restoration.

5. Customized treatments by clinic professionals

We live in an age of personalization. In the context of medical aesthetic treatments, this means that procedures and products are evolving to meet consumer demand for customized treatments and results. It is no longer unusual to develop treatment plans that are tailored to individual needs, facial structures, body proportions, and skin types.

The adoption of customized aesthetic services can lead to more comfortable and satisfying experiences for patients. Aesthetic practitioners must protect the well-being of their patients at all times, ensuring that treatments are safe, effective, and personalized to meet individual needs. This commitment to patient care is essential for maintaining trust and delivering high-quality outcomes.

In parallel, the importance of high-quality aesthetic clinical trials to assess the efficacy of products, devices, and procedures, as well as their inter-compatibility, cannot be underestimated. Clinical research is crucial for testing and regulating all cosmetic equipment and products, including neuromodulators, dermal fillers, and injectable drugs. These trials must be conducted ethically, with research participants representing a diverse population that reflects a realistic segment of future users. Ethical clinical trials are essential for generating reliable data, ensuring patient safety, and preserving trust in the medical aesthetics industry.

By clearly distinguishing between clinical care and clinical research, we can ensure that both patients and research participants receive the highest standards of care and ethical consideration.

Quality research is crucial for testing and regulating all cosmetic equipment and products to preserve public trust in the medical aesthetics industry.

6. Technological advancements

The development of new technologies and innovative treatments is both driving and responding to the growing demand for aesthetic medicine procedures. These advancements are expected to enhance patient comfort and improve results. For example:

  • Virtual reality pain management can help patients during treatments involving injections or laser procedures, promoting relaxation before and after sessions.
  • Wearable skincare devices administer treatment compounds gradually throughout the day, increasing comfort and convenience.
  • New neuromodulator formulations offer longer-lasting and fast-acting results, come in ready-to-use liquid forms, and include stabilizers free from human or animal by-products.
  • Non-surgical skin treatments, such as fractional laser resurfacing and IPL, allow for highly precise treatments tailored to individual skin concerns, leading to more natural results. Treatments like ultrasound skin tightening and radiofrequency therapy stimulate collagen and elastin production, improving skin firmness and texture over time.
  • Laser treatments for acne target sebaceous glands to reduce oil production, offering long-lasting results through simple procedures. Blue light therapy devices, such as laser pens and LED wands, are non-invasive and popular for their convenience and ease of use at home.
  • AI diagnostics and 3D imaging enable more precise treatment planning, potentially reducing discomfort and improving outcomes.

As companies invest in developing advanced technologies, it is crucial that each procedure, product, and device undergo thorough testing to meet the increasingly stringent regulatory requirements. An established, globally-recognized biotech CRO like ethica plays a key role in ensuring the effectiveness and safety of each product. They provide the necessary evidence and research results to obtain regulatory approval, set realistic expectations, and establish procedural standards for manufacturers, clinics, and providers. 

The aesthetic medicine market depends on high-quality, ethical clinical trials

Trends in aesthetic medicine may evolve and shift, but the core goal remains the same: to enhance patient quality of life through effective, innovative cosmetic treatments. To achieve this goal and maintain consumer trust in this growing industry, it is essential that practitioners and users rely on products, devices, and procedures that have been rigorously tested by qualified CROs.

At ethica, we have extensive experience conducting ethically superior, complex clinical trial projects. With a unique research participant-centered approach to all aesthetic medicine trials, we are proud to be the first CRO in the world to have acquired HRPP accreditation. Our priority is to perform inclusive studies that adhere to the highest standards of medical ethics.

If you are searching for the right resource to test your product or device, we invite you to contact us  to find out how we can help you.

Top Medical Aesthetics Trends, Treatments & Tech for 2025

Woman receiving medical aesthetics treatment with laser hair removal

The aesthetic medicine industry is undergoing transformative changes driven by advancements in technology and evolving consumer preferences. Aesthetic medicine trends in 2025 are characterized by innovation, personalization, minimally-invasive procedures, and a focus on natural beauty. From advanced AI diagnostics and hybrid treatments to the integration of wellness and regenerative medicine approaches, evolving consumer demands highlight the industry’s shift towards more advanced, regulated, user-friendly, and patient-centric treatments.

Let’s explore the progressive trends, treatments, and technologies that are set to make 2025 a memorable year in medical aesthetics worldwide.

Medical aesthetics: top trends in 2025

Aesthetic medicine trends are about more than new technologies and procedures: they are the natural development of evolving patient expectations and practitioners’ overall approach to every element of diagnosis, treatment, and care.

This year will continue to mark the rise of personalized, patient-centric experiences driven by user education and the desire for natural-looking results. Diversity is key, as the expanding global market creates a demand for services tailored to every genetic type. Patients are demanding procedures that prioritize convenience and collaboration and offer minimal downtime. These are the medical aesthetics trends that will shape 2025:

Personalized, patient-centered approach: collaboration and customization

The aesthetics industry is showing a profound shift towards a quality-centric, personalized approach. In a two-fold change that involves both patients and practitioners, this transformation focuses on collaborating with patients to create custom treatment plans and outcomes.

Overall, customization is becoming a cornerstone of aesthetic medicine. Practitioners aim to tailor treatments to meet individual patient needs and preferences, striving to achieve results that align closely with patient expectations. This bespoke approach enhances the patient experience by focusing on personalized care and realistic outcomes.

Collaboration between patients and practitioners

Today’s patients play an active and empowered role in their treatment decisions. The doctor’s expertise is no longer the sole element in determining the treatment path.

With increased access to knowledge about procedures and technologies, patients are now aware of their choices and better prepared to partner in their own aesthetic journeys. They are invited to share their unique preferences and treatment goals with practitioners so they can work together from start to finish.

Patient well-being: a regulated approach that includes patient education

In 2025, patient safety will remain at the forefront, with stringent protocols and rigorous standards continuing to be the cornerstone of the medical aesthetics industry. Practitioners will prioritize safe and regulated environments, ensuring high standards of care and adherence to best practices.

Patients are actively seeking practitioners who prioritize their well-being and health by offering aesthetic enhancements in a secure and regulated setting. They expect practitioners to uphold high standards and established best practices.

Governments and medical associations continue to improve the regulation of aesthetic medicine practices and practitioners, and to enforce the use of products, devices, and procedures that offer clinically proven results. The role of biotech CROs in performing high-quality, inclusive, and ethically stringent clinical trials cannot be underestimated.

Patient education

In this digital age, patients actively seek information online and do thorough research to learn about procedures and technologies. Online resource centers guide individuals through every facet of their aesthetic journey, providing comprehensive insights into treatment options, recovery strategies, and post-treatment care. Armed with this knowledge, patients are confident in making informed decisions and are developing a sense of ownership over their aesthetic choices.

Online reviews and testimonials remain influential, especially within the sphere of social media. Patient narratives provide a real-world perspective on aesthetic procedures, helping interested users make informed decisions and guiding them towards reputable practitioners and treatments. In today’s medical aesthetics market, data isn’t just a luxury—it’s a necessity. Consumers are increasingly discerning, demanding transparency, efficacy, and results backed by science. This shift has reshaped the industry, pushing it beyond traditional treatments toward evidence-based, health-focused aesthetic solutions.

Data plays a vital role in educating patients by providing objective evidence of treatment efficacy, identifying gaps in offerings, and debunking marketing hype. Clinical trials and laboratory studies reveal which procedures and technologies are genuinely effective, helping patients make informed decisions. By understanding the science behind treatments, patients can confidently choose options that are safe, effective, and tailored to their specific needs.

Choosing the best treatments

Because of the extensive information available to patients, there is a growing awareness that quality treatments offer superior results and peace of mind. Patients prefer to invest their time and resources in treatments that are tested and proven to be safe, effective, and long-lasting. ‘Quick-fix’ procedures are no longer as popular as they once were.

Aligning with this patient-driven trend, practitioners are choosing to invest in reliable, clinically-tested products, devices, and procedures that provide patients with high-quality treatments that meet their expectations.

Mindful and holistic aesthetic medicine: naturally beautiful results

Mindful aesthetics reflects a shift towards minimal, sustainable, and natural-looking results. Consumers are looking for treatments and products that align with ethical values and have minimal environmental impact. This trend is supported by the rise of the global natural and organic beauty market. Mindful aesthetics emphasizes transparency, sustainability, and the use of products that integrate seamlessly with the body.

Holistic approach, natural-looking results

With subtlety in mind, treatments are increasingly designed to enhance an individual’s existing features and achieve outcomes that blend seamlessly with their unique attributes. Today’s patients wish to confidently present their authentic selves, without fear of appearing overly-altered.

Practitioners are also expected to integrate elements of overall mental and physical health into cosmetic treatments. This holistic approach considers patient well-being and combines aesthetic procedures with wellness practices such as nutritional advice and mental health support.

Embracing diversity and inclusivity

The beauty industry is embracing values of diversity and inclusivity more than ever before, in clinical trials, professional settings and advertising.

In 2025, this will extend to the design of products and procedures that accommodate individuals from different backgrounds, a multitude of skin types, various age groups, and diverse gender identities.

An inclusive approach reflects the trending concept that beauty transcends boundaries and stereotypes. Advanced AI and machine learning algorithms can analyze individual patient data, including facial structure, skin type, and aging patterns, to tailor treatments uniquely to each person. Clinical trials for aesthetic medicine procedures involving neuromodulators, dermal fillers and injectable drugs are also expected to reflect this trend by enrolling a diverse range of participants.

Minimal downtime and procedures that prioritize convenience

In 2025, convenience continues to take the center stage. Minimal downtime means patients undergoing a procedure in the morning could effortlessly return to their daily routines by the afternoon. Aesthetic procedures are expected to be easily integrated into daily life while offering exceptional results.

Medical aesthetics: top treatments in 2025

Medical aesthetics treatments in 2025 are characterized by the importance of non-invasive procedures and consultations, hybrid treatments, dermal fillers and proactive beauty.

Non-invasive procedures and consultations: easy and effective

In 2025, the popularity of non-invasive and minimally-invasive procedures continues to surge. Procedures that offer an alternative to surgical interventions, such as energy-based devices (laser and radiofrequency technologies), topical formulations, and hair restoration treatments are at the forefront. Minimally-invasive procedures, including dermal fillers and neuromodulators, also continue to rise in popularity as they require little downtime.

Overall, pain-free alternatives are ushering in a new era of accessible, convenient aesthetic procedures. Comfort, safety, and efficacy are key. Virtual consultations are also becoming more accessible thanks to AI. The goal is for individuals to be able to pursue their aesthetic goals easily and at their own convenience.

Hybrid treatments

In 2025, hybrid treatments are at the forefront of medical aesthetics, representing a fusion of various modalities to save time and deliver exceptional results. These treatments combine different technologies, such as Radio Frequency (RF) and ultrasound, to enhance the effectiveness of aesthetic procedures by targeting multiple layers of the skin simultaneously. Additionally, hybrid treatments integrate different medical specialties, such as combining dentistry and aesthetic medicine, to provide comprehensive facial rejuvenation. This holistic approach addresses both dental aesthetics and skin appearance in a single treatment plan, offering patients a more convenient and efficient experience. The trend of creating a comprehensive aesthetic experience is soaring, with patients seeking treatments that offer multiple benefits in one session, reducing the need for multiple appointments and recovery periods.

The rise of GLP-1 medications like Ozempic®, primarily used for weight loss, has introduced new considerations in aesthetic treatments. These medications can lead to significant weight loss, resulting in changes to skin elasticity and volume. Consequently, there is an increased demand for procedures that address these changes, such as facial fat grafting, skin tightening, and collagen biostimulators. Integrating these treatments into a comprehensive aesthetic plan helps patients achieve a more balanced and natural appearance.

Proactive beauty treatments

Proactive beauty, or “prejuvenation,” focuses on preventing the signs of aging before they become apparent. This trend includes the use of at-home devices, cosmeceutical skincare, and smaller, less invasive “tweakments” to maintain youthful skin. Proactive beauty emphasizes early intervention and ongoing maintenance.

Treatments that build on the body’s own ability to heal

Polynucleotide treatments are gaining traction for their ability to enhance overall skin health and appearance. These naturally occurring molecules help to regenerate and repair damaged skin by promoting cellular activity. They are particularly effective in improving skin texture, elasticity, and hydration, offering a natural alternative to traditional fillers and injectables.

Biostimulators, such as poly-L-lactic acid (PLLA) and calcium hydroxylapatite (CaHA), are also becoming increasingly popular. These substances are injected into the skin to stimulate the production of collagen and other extracellular matrix components. This results in improved skin texture, elasticity, and volume over time. Biostimulators offer a gradual and natural-looking enhancement, making them a preferred choice for many patients seeking long-term results.

Also part of a broader trend towards treatments that support the body’s natural processes, amino acid injectables use amino acids to stimulate collagen production and improve skin elasticity, offering subtle and natural-looking enhancements.

Integrated skincare

Integrated skincare combines in-clinic procedures such as injectables, lasers, and microneedling with high-quality, science-based skincare products. By supporting professional treatments with effective at-home skincare routines, patients can maximize and prolong the benefits of their aesthetic procedures.

Medical aesthetics: top 5 technologies in 2025

The medical aesthetic technologies that will shape 2025 reflect the priorities and developments described in the above ‘trends’ and ‘treatments’ sections. Popular technologies support practitioners and patients in their goals of offering personalized, minimally-invasive aesthetic treatments. As with any new technology, the emergence of these innovations will require extensive research to ensure long-term safety and efficacy, thereby building consumer confidence.

1. At-Home Skin Rejuvenation Devices

The skin rejuvenation devices market has experienced significant growth driven by advancements in technology and increasing consumer demand for non-invasive aesthetic treatments. Innovations such as laser therapy, intense pulsed light (IPL), and micro-needling devices have transformed skin care routines and treatment options. These technologies offer solutions for a range of skin issues, including wrinkles, fine lines, pigmentation, and elasticity loss, making them highly attractive to a diverse age group.

Moreover, the advent of at-home devices has expanded the accessibility of skin rejuvenation treatments, previously confined to dermatology clinics and medical spas. These devices incorporate cutting-edge technologies like fractional photothermolysis and ultrasound, previously only available in professional settings, thus broadening the consumer base. However, ensuring the safety and efficacy of these devices, especially when handled by untrained consumers without clinical supervision, may present significant regulatory and validation challenges. Rigorous data collection and analysis are essential to ensure these devices meet stringent safety standards and are validated for consumer use.

2. Body contouring and sculpting

Non-surgical body contouring and sculpting technologies such as cryolipolysis (fat freezing), radiofrequency, and ultrasound offer a convenient and effective way to achieve a more toned and contoured physique. However, as they gain in popularity, these technologies face several clinical, regulatory, and safety challenges. Clinically, achieving consistent and effective results across diverse patient populations can be difficult. Regulatory challenges include meeting stringent safety standards and obtaining approval from health authorities, which requires comprehensive clinical trial data. The FDA’s recent draft guidances for the 510(k) program, released in September 2023, further emphasize the need for robust clinical data and careful selection of predicate devices.

By conducting thorough clinical trials and long-term studies, manufacturers can differentiate their products and provide robust safety and efficacy data. This not only helps in gaining regulatory approval but also builds consumer trust and ensures the long-term success of these technologies.

3. Skinalysis

Skinalysis is the use of advanced scientific instruments for skin analysis. They help gain insights into various skin parameters, including hydration levels, pigmentation, and collagen density. To ensure these insights are accurate and reliable, rigorous validation of the instruments is essential. This validation process confirms the precision and consistency of the data across different skin types and conditions. The validation of these technologies is particularly critical when they are employed to support primary outcomes in pivotal clinical trials. Consequently, the selection process for these instruments necessitates the expertise of experienced Contract Research Organizations (CROs). This rigorous, data-driven approach ensures the provision of personalized skincare recommendations and more precise treatments. This data-driven approach allows for personalized skincare recommendations and more precise treatments.

4. Breakthrough laser treatments

New laser technologies are achieving better results in skin resurfacing and pigmentation correction. Innovations in laser wavelengths allow for safer, more effective treatments, expanding the possibilities for non-surgical facelifts and body sculpting.

For acne sufferers, laser treatments target and suppress the oil-producing glands responsible for acne, addressing the root cause of the condition. Unlike traditional acne treatments that focus on symptom management, new treatments offer a more targeted and effective solution, making them a game-changer for acne sufferers in 2025.

These advancements, however, come with regulatory and safety challenges that require thorough validation and adherence to strict guidelines to ensure patient safety and treatment efficacy. Given their innovative nature, these breakthrough laser technologies are likely to be tested via the Investigational Device Exemption (IDE) route rather than through the 510(k) program, necessitating extensive clinical trials to demonstrate their safety and effectiveness.

5. Regenerative medicine

Regenerative medicine, including stem cell and platelet-rich plasma (PRP) therapies, is on the rise. These treatments leverage the body’s natural healing processes to improve skin tone, texture, and overall appearance by stimulating collagen and elastin production. However, the rapid advancement of these technologies has outpaced regulatory frameworks, leading to uncertainty over product quality and future safety and efficacy requirements. Ensuring regulatory compliance involves rigorous evaluation, comprehensive clinical trials, and addressing potential risks such as infection and immune reactions.

Exosome-Based Treatments

Exosome-based treatments are gaining traction for their ability to enhance skin rejuvenation and repair. Exosomes are extracellular vesicles that facilitate cell-to-cell communication and play a vital role in tissue repair and regeneration. They can deliver growth factors and other bioactive molecules directly to target cells, promoting skin healing and rejuvenation. This approach offers a natural-looking enhancement and is expected to be a major trend in 2025. However, exosome-based treatments face regulatory challenges due to their unique mechanisms of action and lack of standardization, as well as safety concerns such as immune reactions and quality control issues. Rigorous validation and ongoing monitoring are essential to ensure their safety and effectiveness.

An evolving medical aesthetics industry demands stringent testing and regulation

The aesthetic medicine industry is undergoing transformative changes driven by advancements in technology, evolving consumer preferences, and a growing emphasis on minimally invasive procedures. The trends, technologies, and treatments that will be shaping 2025 reflect the priorities and preferences of a new medical aesthetics industry.

The importance of testing and regulation in maintaining consumer trust and treatment standards cannot be underestimated. A globally recognized CRO like ethica plays a crucial role in determining the effectiveness and safety of each product and device. By providing the necessary evidence and research results for regulatory approval, ethica helps set realistic expectations for both practitioners and patients. Additionally, ethica’s extensive expertise in medical aesthetics and rigorous research methodologies ensure that manufacturers introduce safe products to the market. These products are supported by robust data that health professionals can verify, ultimately leading to enhanced consumer satisfaction and confidence.

As diversity and personalization continue to shape aesthetic medicine practices, our unique research participant-centered approach to all aesthetic medicine trials is more relevant than ever. We are the first CRO in the world to have acquired HRPP accreditation and it is our priority to perform inclusive studies in adherence to the highest standards of medical ethics.

If you recognize the value of incorporating ethical and rigorous clinical trials into your market strategy, we encourage you to contact us to explore how we can support your goals.


Why Rigorous Data is Transforming Skincare: Insights from the Science of Skincare Summit

Science of Skincare Summit 2024

As skincare innovations continue to reshape the industry, the ability to make data-backed decisions is essential for dermatologists, skincare professionals, and industry innovators. With an influx of new products, innovative treatments, and emerging concepts like the microbiome and exosomes, rigorous data serves as the foundation for informed choices, optimized patient outcomes, and industry advancements.

A pivotal event in this domain is the annual Science of Skincare Summit, organized by board-certified dermatologists Dr. Patricia Farris and Dr. Ted Lain. Four years ago, they joined forces to bring to life a conference solely devoted to the science behind skincare, providing a unique platform for exploring cutting-edge developments.

This premier event brought together medical and aesthetic professionals, industry scientists, and key leaders to explore the scientific foundations of skincare. Attendees, including representatives from ethica CRO, had the unique opportunity to deepen their understanding of ingredient science, learn how to build effective regimens, and gain insights into the development, formulation, regulation, and testing of new skincare products.

This article delves into the key areas where reliable data drives skincare forward, while also highlighting the role of Contract Research Organizations (CROs) in providing robust, actionable insights that elevate the credibility and effectiveness of skincare practices.

Introduction: The Shift to Data-Driven Skincare

In today’s skincare market, data isn’t just a luxury—it’s a necessity. Consumers are increasingly discerning, demanding transparency, efficacy, and results backed by science. This shift has reshaped the industry, pushing it beyond traditional beauty products toward evidence-based, health-focused skincare solutions.

Skincare trends like the microbiome and exosomes exemplify this scientific transformation, alongside a growing interest in nutraceuticals. Data-driven decision-making has become critical for dermatologists and skincare professionals, enabling them to evaluate treatments, recommend products, and build trust with patients.

Through data, the skincare industry can deliver innovative solutions that align with evolving consumer expectations. Whether identifying safe ingredients, optimizing treatment protocols, or developing groundbreaking products, reliable data empowers every aspect of skincare innovation.

1. Data-Driven Product Selection: Streamlining and Enhancing Offerings

The skincare market is inundated with products claiming transformative results. For dermatologists and medical spa owners, the challenge lies in curating product selections that genuinely benefit clients. The key to navigating this field is data.

How Data Enhances Product Selection

  • Efficacy Assessment: Data provides objective evidence of whether products deliver on their claims. Clinical trials and laboratory studies reveal which ingredients are genuinely effective.
  • Gap Identification: Analyzing data helps identify gaps in offerings, such as products tailored to specific skin concerns like hyperpigmentation or rosacea.
  • Hype vs. Reality: Reliable data debunks marketing hype, steering professionals toward products backed by scientific validation.

For example, consider the rise of peptide-based anti-aging serums. By analyzing studies on peptide efficacy, practitioners can determine which formulations are most effective and recommend them confidently to patients.

With insights derived from rigorous data, skincare professionals can streamline their offerings, focusing on products that demonstrate both clinical efficacy and align with client needs.

2. Empowering Treatment Regimens: Educating Providers and Patients

A well-informed skincare regimen builds trust and delivers results. Data-driven treatment plans empower dermatologists and medspa owners to provide personalized care tailored to individual needs.

Key Benefits of Data-Driven Regimens

  • Patient Education: Data helps providers explain the rationale behind treatment plans, setting realistic expectations for outcomes.
  • Personalization: Analyzing individual factors like skin type, microbiome composition, and lifestyle enables highly customized regimens.
  • Enhanced Adherence: Patients are more likely to follow regimens when they understand the evidence supporting them.

For instance, a patient with chronic acne may benefit from a regimen combining topical retinoids and oral probiotics. Data demonstrating the complementary effects of these treatments boosts patient confidence and adherence.

By leveraging data, dermatologists and skincare professionals can reinforce their credibility, improve patient satisfaction, and achieve better clinical outcomes.

3. Exosomes in Skincare: A Cornerstone of Regenerative Anti-Aging Treatments

Exosomes, nano-sized vesicles that facilitate intercellular communication, are revolutionizing skincare with their regenerative potential. By carrying bioactive molecules such as proteins, lipids, and RNA, exosomes play a pivotal role in tissue repair, immune modulation, and cellular rejuvenation. Their ability to enhance skin vitality and resilience makes them a transformative tool in addressing the degenerative nature of aging.

Why Exosomes Are Transformative

Aging is increasingly viewed not as a natural process but as a degenerative condition characterized by cellular decline. Exosomes address this by delivering active ingredients directly to target cells, stimulating repair and regeneration. This precision is particularly valuable for anti-aging treatments, skin rejuvenation, hair restoration, and managing concerns like scarring or pigmentation. Moreover, exosomes also serve as biomarkers to assess treatment response, providing both therapeutic and diagnostic benefits. However, ensuring consistent and safe results hinges on robust and reliable data.

What Rigorous Data Validates

The integration of exosomes into skincare regimens requires comprehensive, evidence-based research to:

  • Ensure safety: Adverse event monitoring generates essential data to confirm that exosomes are non-toxic and suitable for clinical use.
  • Verify efficacy: Studies must demonstrate measurable improvements in parameters like skin elasticity, hydration, and wrinkle reduction to validate their benefits.
  • Define standards: Transparency in sourcing, processing, and composition is crucial to build trust and ensure consistent outcomes.

Advancing Anti-Aging Science with Exosomes

The regenerative power of exosomes underscores a broader shift in anti-aging skincare: the move toward precision treatments. Rigorous data helps identify effective ingredients and technologies while ensuring consistency and safety. This approach fuels innovation, paving the way for groundbreaking solutions that address aging at the cellular level.

Exosomes, along with peptides and growth factors, represent some of the most promising tools in this industry. Through detailed analysis of their cellular effects, skincare professionals can recommend treatments that not only combat visible signs of aging but also restore vitality and resilience to the skin.

Practical Applications for Dermatologists and Medspas

By adopting exosome-based treatments grounded in rigorous data, skincare professionals can:

  • Boost patient outcomes: Evidence-based products improve skin health, helping clients achieve their aesthetic and regenerative goals.
  • Enhance credibility: Reliable results reinforce patient trust and position providers as leaders in advanced skincare technologies.
  • Screen out unvalidated products: Robust data ensures only high-quality, scientifically backed exosome products are integrated into treatment offerings.

4. From Within: The Gut-Skin Axis and Nutraceuticals in Skincare

The emerging understanding of the gut-skin axis and the role of nutraceuticals highlights the profound connection between internal health and skin appearance. By addressing skincare from within, these approaches offer new ways to enhance hydration, combat aging, and improve overall skin quality.

The Gut-Skin Connection

The gut-skin axis emphasizes the bidirectional relationship between internal health and skin appearance. Probiotics, prebiotics, and postbiotics have shown significant potential in maintaining skin health by modulating the gut microbiome. Early research highlights their benefits:

  • Enhanced Hydration: Probiotics improve the skin barrier, reducing water loss and supporting skin elasticity.
  • Photoaging Protection: Studies show that probiotics may mitigate UV damage, preserving collagen and reducing oxidative stress.
  • Improved Skin Quality: Prebiotics and postbiotics boost ceramide production, minimizing wrinkles and pigmentation while strengthening the skin barrier.

While these treatments are promising, further research is necessary to validate their efficacy and optimize formulations for maximum benefit.

Nutraceuticals for Skin Health

Nutraceuticals, or dietary supplements designed to enhance skin health, are rapidly becoming a cornerstone of holistic skincare. By providing essential nutrients and bioactive compounds, these products support skin vitality from the inside out. Key findings include:

  • Collagen Peptides: Clinical studies indicate that collagen supplements can improve skin elasticity and reduce the depth of wrinkles.
  • Antioxidants: Vitamins C and E protect against oxidative damage, a key driver of skin aging, while promoting a more even skin tone.

Challenges and the Need for Rigorous Research

Despite their promise, both microbiome-targeted treatments and nutraceuticals face challenges. Variability in bioavailability, inconsistent dosing, and a lack of standardized formulations make it difficult to ensure consistent results. Rigorous research is essential to identify effective combinations, refine dosing strategies, and validate claims. Reliable data will be crucial in elevating these internal approaches from emerging trends to foundational elements of skincare regimens.

5. The Role of Technology in Data Collection: AI and Data Visualization

Advances in technology are revolutionizing how skincare data is collected, analyzed, and applied. Two critical innovations—artificial intelligence (AI) and data visualization—are shaping the future of the industry.

AI in Skincare Research

  • Pattern Recognition: AI identifies correlations in vast datasets, revealing trends and insights that human researchers might miss.
  • Predictive Modeling: AI algorithms forecast treatment outcomes based on patient data, enabling more accurate recommendations.
  • Speed and Efficiency: Automating data analysis accelerates research timelines, allowing faster innovation.

For example, AI-powered platforms can analyze skin imaging data to predict the effectiveness of anti-aging treatments, helping practitioners tailor recommendations to individual patients.

Data Visualization: Making Insights Accessible

  • Interactive Dashboards: Advanced visualization tools translate complex data into actionable insights, simplifying decision-making for clinicians.
  • Patient Communication: Visual representations of data—like graphs showing treatment progress—enhance patient understanding and engagement.
  • Trend Analysis: Dashboards help identify emerging patterns in skincare, such as the rise of specific ingredients or technologies.

By leveraging AI and data visualization, dermatologists and skincare professionals can harness the power of big data to deliver more precise, effective treatments.

The CRO Advantage: Partnering for Reliable Data in Skincare

CROs play a pivotal role in ensuring that skincare products and treatments are backed by reliable, actionable data. Their expertise spans the entire lifecycle of clinical studies, providing comprehensive support in critical areas such as medical writing, study management, and biostatistics. Key advantages include:

  • Expert Medical Writing: CROs deliver precise, scientifically robust documentation to support regulatory submissions, marketing claims, and clinical study protocols.
  • Comprehensive Study Management: From planning to execution, CROs oversee every aspect of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
  • Rigorous Study Monitoring: Through meticulous oversight, CROs verify that studies meet ethical standards and maintain data integrity.
  • Advanced Data Management: By leveraging sophisticated tools and processes, CROs ensure accurate and efficient data collection, storage, and analysis.
  • Biostatistical Expertise: CROs apply advanced statistical methodologies to validate findings and generate meaningful insights from complex datasets.
  • Quality Assurance: With robust quality systems, CROs uphold the highest standards of compliance and consistency throughout the study process.
  • Specialized Medical Affairs: CROs provide strategic medical insights to ensure clinical studies align with broader scientific and commercial objectives.

By offering these end-to-end services, CROs empower skincare professionals to confidently integrate innovative treatments and products into their practices, backed by rigorous data that meets the highest standards of clinical efficacy and safety.

Data as the Cornerstone of Effective Skincare

As the skincare industry evolves, data remains the cornerstone of progress. Dermatologists, medispas, and skincare innovators face growing pressure to deliver results that meet consumer expectations. Rigorous data enables them to rise to this challenge, providing the foundation for safe, effective, and innovative solutions.

Whether selecting products, designing treatment regimens, or exploring advanced technologies, data empowers dermatologists and skincare professionals to lead with integrity. By partnering with CROs, the industry can continue to push boundaries, setting new standards for efficacy, safety, and patient satisfaction.

Data isn’t just an asset—it’s a necessity. By embracing a data-driven approach, dermatologists and skincare professionals can deliver evidence-based treatments that meet client needs, while product innovators can leverage clinical data to develop solutions grounded in proven efficacy, address gaps in the market, and rise above marketing hype with scientifically validated products.

Contact us today to discover how our expertise can support you in building trust, achieving exceptional outcomes, and maintaining a competitive edge in the dynamic field of skincare innovation.

Electronic Participant-Reported Outcomes (ePROs) in Medical Aesthetics Clinical Trials

Older woman using ePROs for clinical trial

Medical aesthetics is one of the most rapidly growing therapeutic fields as research continues to demonstrate its numerous benefits to personal health, including:

  • Improved Self-Esteem: Medical aesthetic therapies can help improve skin appearance and boost self-esteem, leading to increased confidence and a higher quality of life.

  • Improved Physical Health: Some medical aesthetic treatments, such as laser therapy and chemical peels, can improve the health of the skin by promoting cell renewal and reducing inflammation.

  • Reduced Stress and Anxiety: Many skin issues, such as acne, wrinkles, and sun damage, can cause stress and anxiety. Medical aesthetic products can reduce the appearance of these skin concerns leading to a greater sense of well-being.

In this blog post, we will discuss the advantages and challenges of integrating electronic PROs in medical aesthetics clinical trials.

What are patient-reported outcomes (PROs)?

As many of the primary efficacy outcomes of medical aesthetic therapies are subjective (e.g., self-esteem improvement, stress and anxiety reduction, perception of appearance, severity of deficit, etc.), patient-reported outcomes (PRO) (or participant-reported outcomes in the context of clinical research), which refers to the self-reported data collected from research participants about their condition, treatment, and experience, play an important part in clinical trials.

From validated quality of life and self-esteem questionnaires to diaries, PROs are used to support the regulatory approval of investigational aesthetic products. In recent years, electronic PROs have emerged as new and innovative methods for collecting these types of data, replacing the paper diaries that research participants had to complete are return to the clinic at their scheduled visit.

What are the most common PROs used in medical aesthetics clinical trials?

Some of the most common PROs used in medical aesthetics clinical trials include:

  • Wrinkle Severity Rating Scale (WSRS): The WSRS is a commonly used PRO that assesses the severity of wrinkles in the face, neck, and hands.

  • FACE-Q: The FACE-Q is a multi-modular PRO instrument that includes more than 40 independently functioning scales and checklists. The FACE-Q scales measure outcomes that matter to participants, including facial appearance, quality of life, and adverse effects.

  • Patient and Observer Scar Assessment Scale (POSAS): The POSAS is a PRO that measures the appearance, symptoms, and impact of scars on patients’ quality of life.

  • Dermatology Life Quality Index (DLQI): The DLQI is a PRO that measures the impact of skin diseases on a patient’s quality of life.

  • Participant Satisfaction Questionnaire (PSQ): The PSQ is a PRO that measures patient satisfaction with cosmetic procedures, such as dermal fillers and laser treatments.

  • Visual Analog Scale (VAS): The VAS is a PRO that measures pain, itching, and other symptoms on a scale of 0 to 10.

  • Facial Appearance Satisfaction Scale (FASS): The FASS is a PRO that measures patient satisfaction with their facial appearance after cosmetic procedures.

  • Participant Global Assessment (PGA): The PGA is a PRO that assesses the overall improvement or change in a patient’s condition.

These measures help clinical investigators evaluate the effectiveness and research participants satisfaction with the investigative aesthetic product, whether it is a cosmetic/cosmeceutical, drug, or medical device.

What are the advantages of ePROs compared to paper-based PROs?

Electronic Participant-Reported Outcome Measures (ePROs) offer several advantages compared to traditional paper-based PROs, such as:

  • Increased accuracy and reliability: ePROs can use algorithms to ensure the accuracy and completeness of data, reducing the risk of human error and missing data.

  • Real-time data collection: ePROs can be administered at any time and from any location. This is particularly important for participants who may have mobility issues or live in remote areas. ePROs allow for real-time data collection, which is more accurate and reliable compared to traditional paper-based methods where there is a risk of introducing recall bias.

  • Improved participant engagement: ePROs can be designed to be user-friendly and interactive, potentially increasing research participant engagement and motivation to participate. By using digital tools, research participants are more likely to complete the assessments and provide valuable feedback, which can help improve the overall quality of the trial.

  • Reduced administrative burden: ePROs can automate data entry and analysis, reducing the administrative burden on research staff and improving efficiency.

  • Increased data security: ePROs can use secure electronic systems to protect research participant privacy and confidentiality, reducing the risk of lost data, data breaches, and other unauthorized access to sensitive information.

  • Cost savings: ePROs can save time and reduce costs associated with data entry, printing, and shipping of paper-based PROs.

Compared to traditional paper-based PROs, ePROs offer several advantages including increased accuracy, real-time data collection, improved research participant engagement, reduced administrative burden, increased data security, and cost savings.

What are the challenges of integrating ePROs into medical aesthetics clinical trials?

It is important to consider that ePROs also present new challenges that must be addressed to ensure the successful integration of ePROs into medical aesthetics clinical trials (e.g., technical support, internet access, access to appropriate devices such as smartphones or tablets).

Technical Challenges

Electronic PRO relies on technology that can be prone to technical difficulties such as software malfunctions and network disruptions. Technical issues, such as software compatibility and lost data, can impact the accuracy and completeness of clinical trial data.

Therefore, it is important to not only use technologies with solid infrastructures, proven track records and responsive trouble-shooting processes, but also to properly validate and test the technologies prior to their deployment.

Data Quality

While ePROs can increase the accuracy and reliability of clinical trial data compared to traditional paper-based PROs, the quality of ePROs data is dependent on several factors, including the design of the questionnaire, the research participant’s ability to use the technology, and the level of training provided to both the investigational teams and research participants.

Site-specific training on ePROs is an essential component of the investigational site initiation process as well as on-demand support from clinical project managers.

Research participant enrolment difficulties

As with any PRO, research participants may feel that the burden of reporting symptoms/outcomes through ePROs is too high. Participants may feel that the time commitment required to complete the ePROs is too much, especially if they have other responsibilities or obligations; a problem that is common to any PROs used in clinical trials. Furthermore, not all research participants may have access to digital devices compatible with the proposed ePRO technologies or be comfortable using them.

Indeed, despite the benefits of electronic PROs, some research participants may be hesitant to use the technology or may not fully understand how to complete the questionnaire. Research participants may also be skeptical about the reliability of ePROs and may question the accuracy of the information they are reporting. This can result in a limited research participant population, which can either impact the generalizability of the trial’s results or delay research participant enrolment timelines.

As overcoming research participant resistance and promoting the benefits of electronic PROs can be challenging, it is essential that the CRO provides investigational sites with the tools and support necessary to face these potential objections.

Data Analysis

The large amounts of data generated by ePROs can pose a challenge for trial teams in terms of data analysis and interpretation. Ensuring that the data are analyzed and interpreted accurately by the CRO’s data management team is critical.

Privacy and Security Concerns

While they provide added security compares to paper-based PROs, electronic PROs do involve collecting sensitive personal and medical information which raises concerns about privacy and security.

It is essential to ensure that the digital tools used in a trial comply with data protection regulations such as HIPAA, PIPEDA, and GDPR, as well as applicable state and provincial privacy legislation. It is also fundamental that research participant data are protected from unauthorized access. Robust cybersecurity measures are necessary to protect the data.

Regulatory Compliance

Beyond privacy legislations, ePROs are also subject to various regulations and guidelines and it can be challenging to ensure compliance. For example, the FDA has elaborated specific requirements for the acceptance of ePROs in clinical trials.

What are FDA requirements for including ePROs in a clinical trial?

The US Food and Drug Administration (FDA) has established guidelines[1] for the use of electronic Participant-Reported Outcome Measures (ePROs) in clinical trials. The FDA requirements for including ePROs in clinical trials are similar to those for traditional PROs and include the following:

  • Validity: The ePRO must be valid, meaning it accurately measures what it is intended to measure. This includes a review of the development and testing of the ePRO and its ability to produce consistent results.

  • Reliability: The ePRO must be reliable, meaning it produces consistent results when used with the same research participants over time. This includes a review of the stability and consistency of the ePRO results.

  • Sensitivity: The ePRO must be sensitive to change, meaning it can detect changes in the research participant’s health status over time. This includes a review of the ePRO’s ability to detect changes in the research participant’s quality of life, health status, and or sign/symptom severity. This is a fundamental component to minimize risks to research participants, a requirement under the ethical principle of beneficence.

  • Relevance: The ePRO must be relevant, meaning it is appropriate for the research participant population being studied and the goals of the clinical trial. This includes a review of the ePRO’s ability to accurately capture information about the research participants’ health status and quality of life, as previously discussed above.

  • Statistical Analysis: The data collected using the ePRO must be analyzed in a way that is statistically meaningful and appropriate. This includes the use of appropriate statistical methods to analyze the ePRO data and the presentation of results in the clinical study report and scientific publications in a way that is easily understandable.

  • Data Security: The ePRO must be secure and protect research participant privacy. This includes the use of secure servers and encryption to protect the data and the implementation of strict data access controls to prevent unauthorized access to the data.

  • Electronic Recordkeeping: The ePRO data must be kept in a format that complies with FDA regulations for electronic records and electronic signatures (21 CFR Part 11). This includes the use of electronic signatures, secure storage, and electronic backup procedures to ensure the integrity of the data[2].

Overall, the FDA requires that ePROs used in clinical trials meet certain standards for validity, reliability, sensitivity, relevance, statistical analysis, data security, and recordkeeping.

The FDA also requires that the results of ePROs be reported in a clear and concise manner and that the information gathered using ePROs be used to support the approval of new medical aesthetic treatments.

How to successfully implement ePROs in medical aesthetics clinical trials

Integrating electronic PROs in clinical trials requires careful planning and attention to detail to overcome the above-mentioned challenges and to ensure that trials are conducted effectively and efficiently.

When research participants are asked to use their own devices to complete ePROs, several strategies can be employed to ensure a successful and seamless experience. These strategies include:

  • Informed consent: To ensure that research participants make an informed decision about using ePROs to collect their health information the informed consent process should explain the type of information that will be collected by the ePRO and how that information will be used by the research team. The informed consent process should also specify who may have access to data collected through the ePRO during or after the clinical trial (e.g., sponsor, CRO, investigator, research participant, ePRO service provider, other third parties) and for how long.

  • Device compatibility: Ensuring that the ePRO platform is compatible with the most commonly used devices, such as smartphones and tablets, to minimize technical difficulties.

  • Accessibility: Ensuring that the ePRO platform is accessible to participants with disabilities, such as those with visual or hearing impairments, using accessibility features, such as screen readers and magnifiers.

  • User-friendly design: Designing the ePRO platform to be user-friendly, with clear instructions, and an intuitive interface to minimize research participant confusion and frustration.

  • Technical support: Providing both investigational sites and research participants with easy access to technical support, such as a help desk or online resources, in the event that technical difficulties are encountered.

  • Data security: Ensuring that participant data are securely stored and protected from unauthorized access, and that the participant data are de-identified to protect privacy.

  • Compensation: Offering participants a financial compensation for their time completing the ePROs shows respect and may ensure research participant compliance. Other non-financial incentives, like access to additional resources, may increase research participants motivation and engagement in the study.

  • Communication: Regularly communicating with investigative sites and research participants to keep them informed about the study and to provide updates on the status of their data may also contribute to research participants’ motivation and engagement in the study.

Improve the quality of your clinical trials with ePROs

Electronic PROs can significantly improve the quality of medical aesthetics clinical trials. However, it is important to address the associated challenges such as technical difficulties, research participant engagement, privacy/security concerns, and regulatory compliance.

By addressing these challenges, electronic PRO can help improve research participant-reported outcomes measurements in clinical trials and bring safer and more efficient medical aesthetics products on the market.

Strategies such as device compatibility, accessibility, user-friendly design, technical support, data security, acceptable compensation and incentives, and communication can help ensure a successful and seamless experience. These strategies can help increase participant engagement and satisfaction while ensuring the integrity and validity of the study data.

Ethica CRO is a medical aesthetics and dermatology CRO that employs ePRO as part of our suite of real-time data management technology. Contact us today to learn more about our multidisciplinary team with extensive scientific expertise and a wealth of clinical management experience for managing your medical aesthetics clinical trials.


[1] Food and Drug Administration, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”, Draft Guidance, December 2021, online: https://www.fda.gov/media/155022/download ; See also Food and Drug Administration, “Patient-Reported Outcome Measures:  Use in Medical Product Development to Support Labeling Claims”, Final Guidance, December 2009, online: https://www.fda.gov/media/77832/download .

[2] Food and Drug Administration, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers”, Draft Guidance, March 2023, online: https://www.fda.gov/media/166215/download

What is a Contract Research Organization (CRO)?

contract research organization employee

What is a Contract Research Organization (CRO)?

Clinical studies are undertaken to determine whether a given investigational product is safe, effective, and ready for use. A variety of products are tested as part of clinical studies from drugs, biologics, and medical devices, to cosmeceuticals and digital applications. Since these products are tested on and intended for humans, clinical studies are subject to strict regulatory standards. The research processes, data and conduct must be above reproach for the study to be considered valid and the product to be approved.

Contract research organizations can provide a variety of services to support those undertaking clinical studies and help them conduct successful research. Find out everything you need to know about CROs in this article!

What is a CRO?

A contract research organization is a company that provides clinical research services for studies in the pharmaceutical, biotechnology, medical device, and digital application industries. Various aspects of clinical study management can be outsourced to CROs, eliminating the need for manufacturers (also known as ‘sponsors’) to hire a permanent team for a single project.

A contract research organization can take care of planning and management operations throughout the lifecycle of a clinical trial and coordinate with regulatory bodies, vendors, and physicians at every step of the way.

The advantages of working with a CRO

Contract research organizations have the expertise, tools and framework necessary to develop and run a successful clinical trial that complies with regulatory standards. Working with a CRO can improve efficiency, speed up the timeline and reduce the cost of a study.

Services offered by contract research organizations

Contract research organizations (CROs) are invaluable partners for companies and organizations who need to outsource their research and development. These independent entities provide comprehensive scientific and technical research services to clients across a range of industries, including biotechnology, pharmacology, engineering and more.

CROs can help clients develop innovative products, optimize existing processes, study the feasibility of projects, and resolve complex problems. Let’s take a closer look at the services these organizations offer and how they can benefit companies.

Medical writing

A CRO can provide professional medical writing services that include a wide range of documents that are vital to the success of a clinical study.

Well-written study protocols can speed up the ethics and regulatory review process, eliminate or limit the need for amendments, and prove easier for researchers to understand and implement. Informed consent forms must be carefully crafted to educate research participants about the proposed research in a way that is clear, concise and easy to understand so that they can make an informed decision about their participation.

CROs can also generate complete, accurate, unbiased research reports and prepare study results for presentation and publication.

Clinical trial management

Taking a therapeutic product from development to approval is an increasingly complex process. It requires specialized clinical trial management that can oversee everything from finances to regulatory compliance.

A contract research organization can develop a thorough, comprehensive project management plan and provide the services of expert project managers to oversee budgeting, logistics, communications, research monitoring, quality control, regulatory reporting and more.

Clinical trial monitoring

Monitoring is required at every stage of a clinical study’s lifecycle to ensure the integrity of the project. Contract research organizations can provide both on-site and centralized clinical trial monitoring services and implement risk management to both minimize and mitigate unanticipated problems.

A CRO will run regular data analyses and use advanced software to identify data anomalies and potential protocol deviations. With a pre-emptive approach that promotes early risk detection, appropriate corrective measures can be taken in a timely manner to avoid negative consequences for the study.

Data management

Clinical research data provide the evidence of whether your study’s objectives have been achieved and whether your product or treatment is ready for approval. Accurate data generation, analysis and management are crucial to the success of any study.

CROs offer professional clinical trial data management services. Expert data collection and management can make regulators, publishers and investor more inclined to trust the results. A CRO can ensure that all data is properly organized, formatted and annotated and use advanced data visualization technology for clear, accurate, transparent reporting.

Biostatistics

A clinical study requires a comprehensive plan that details the statistical strategy and methodology used. A contract research organization can help with clinical research biostatistics, developing statistical analysis plans, designing protocols, determining sample size, etc. to create an objective operational framework that is efficient, effective and prevents bias.

Medical affairs

CROs provide medical affairs services for those who want to explore new potential indications for a therapeutic product or treatment. Investigator initiated trials (IITs) can be challenging because they have all of the same responsibilities and tasks to accomplish as conventional clinical trials, but are generally constrained by a lower budget. A CRO can ensure that an IIT’s budget is properly prioritized to maximize the chances of a successful study without wasting any resources.

Tailored clinical trial services at every stage

CROs can be contracted to manage a clinical research project from start to finish or to integrate additional resources and services into an existing research team. Whether they are working on early phase clinical trials or late stage clinical trials, CROs can tailor their approach accordingly.

How to choose a CRO

When selecting a contract research organization, it’s important for sponsors to carefully assess the company’s qualifications, experience and operational processes in addition to the needs, requirements and budget of their study. Here are a few criteria to keep in mind when considering candidates:

Work with ethica CRO for ethical clinical research support

ethica CRO is a biotech CRO that focuses on the ethical dimension of human clinical research. With our Human Research Protection Program, we are committed to protecting the rights and welfare of research participants, safeguarding their data and ensuring the integrity of every clinical study we are involved in.

We work closely with our clients to create a safer environment for research participants, minimize risks, ensure regulatory compliance and streamline procedures for increased efficiency. We provide a wide range of clinical research support and can tailor our services to meet the needs of your study.

Feel free to contact us for further information about our services or submit a request for a proposal. We will be happy to discuss your needs.

The Value of Women-Led Business at ethica CRO

women-led business

In Canada, women are still underrepresented in business leadership roles, but the gap is closing fast—the number of women-owned companies in the country increased by 33% from 2005 to 2013 alone. This progress is vital not just in terms of gender equality, but also because women-led businesses outperform their male-led counterparts in terms of innovation, profitability and employee satisfaction.

It’s clear that women bring something unique and valuable to business leadership, and that influence is unmistakable at ethica CRO. Founded in 2002 by Janice Parente, our company focuses on the ethical dimension of human research. ethica CRO is committed to protecting the rights and welfare of research participants and treating them as valued partners rather than subjects.

There’s no question that ethica CRO is an innovator in the field of clinical research. We are the first CRO in the world to achieve human research accreditation, and the only CRO in the world to achieve accreditation from three different independent, industry-recognized organizations. Our Human Research Protection Program ensures the protection of research participants, compliance with all applicable laws and regulations, and the integrity of clinical study data.

In addition to having a female founder, ethica CRO’s core services are led by women. The result is an innovative, successful company that values diversity, inclusion, equity and respect in both its employment practices and clinical research. ethica CRO strives to develop strategies for breaking the bias in clinical trials and aims to bring therapies to market that will improve the standard of patient care.

For the dedicated, driven, compassionate women at the helm of ethica CRO, care, quality and justice matter. It is with those values in mind that clinical research can truly create a healthier, brighter future for all.