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:

• Do they have a well-established quality management system?
• Do they promote collaboration and communication with all stakeholders?
• Can they conduct audits to assist with preparations for regulatory inspections?
• Do they provide additional services beyond study monitoring, such as project management, site support, etc.?
• Do they have the type of clinical research expertise needed? (dermatology CRO, medical aesthetics CRO, dermal filler CRO, medical device CRO, etc.)

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.