Applying our clinical expertise to your dermatology research program.
Dermatology is a unique and often complex therapeutic area for conducting clinical research, which is why it is crucial to select a CRO with ample experience in dermatology research to manage your study.
ethica CRO is highly experienced in the following areas:
Psoriasis, atopic dermatitis, seborrheic dermatitis, etc.
fillers, botulinum toxin, topical retinoids, laser/light treatments, etc.
Dermatological studies often face a number of challenges throughout their lifecycles. In order to become accepted by regulatory agencies, many endpoints based on qualitative and subjective assessment scales will require robust validation. Additionally, it is often the case that environmental and seasonal factors confound study results and affect research participant recruitment as well as study compliance.
Several study designs also employ novel assessment tools and may require specialized services such as photography or dermopathology in order to achieve their primary study outcome.
When it comes to your dermatology research program, we are eager to provide insight and strategic guidance to ensure that your study offers optimal research participant experience and viable clinical outcomes. Our dedicated team of clinical experts will effectively design and manage your drug, medical device, or aesthetic study.
At our biotech CRO, not only do we understand the challenges of dermatological research, but we also know how to effectively leverage these obstacles within your clinical study’s design and logistics. Whatever hurdle you may come across during your research program, ethica CRO has the right tools and experience to ensure your study’s success.
Since its inception, ethica CRO has completed over 170 dermatology studies.
Our team will help you:
An Asian biopharmaceutical company retained the CRO services of ethica for the design and management of a first-in-man clinical study to be run in the United States. The study presented several technical and logistical challenges including time zone coordination, PK assay transfer and validation, central laboratory management, and comprehensive safety monitoring.
Given the geographic dispersion of the study’s stakeholders, an integrated communication strategy was vital. Utilizing digital collaboration platforms and adapting schedules across time zones facilitated effective coordination between the biopharmaceutical company, ethica CRO, and trial site.
The integrity of clinical safety tests (e.g., hematology, chemistry, thyroid function, and urinalysis) and PK sampling/analysis depended on standardized processes across multiple central laboratories. A centralized data management system was implemented for real-time data sharing and analysis, accompanied by rigorous standardization of lab procedures and quality control measures.
To ensure research participant safety, an enhanced monitoring protocol was established. This involved detailed dermatological assessments to promptly identify adverse reactions, thereby maintaining the integrity of the trial data and ensuring participant well-being.
The study successfully met its primary endpoints, demonstrating the safety and tolerability of the topical drug across the administered doses. Furthermore, the collected pharmacokinetic data provided essential insights for dosing strategies in subsequent phases of clinical development. The successful completion of the study, within the allocated timeline and budget, attests to the effectiveness of the technical and logistical strategies implemented.
The collaborative approach between ethica CRO, its client and the dermatology investigative site coupled with strategic management of technical challenges, was pivotal in navigating the complexities of this first-in-man clinical trial.
