Clinical Development is the process of bringing new medicines, devices or treatments through scientific experiments to the market. It involves conducting clinical trials on humans to evaluate effectiveness and safety of these new products. Typically there are 3 phases until approval (I, II, III) with an increased number of participants. Phase IV is after product launch.
Important functions conducting clinical development are e.g.
Clinical Operations:
Clinical Operations is operationalizing the clinical trial, conducting clinical trial management, initiating sites/hospitals in the clinical trial, conducting monitoring of the clinical trial (often a separate function).
Clinical Data Management / Data Sciences:
Clinical Data Management is ensuring availability, collection, integration and integrity of the clinical data at appropriate quality and costs. This includes various data sources: from electronic Data Capture (eDC, Case Report Forms) at the site/hospital, to ePRO/eCOA (electronic questionnaires), to other external data sources (lab, external assessments, etc.).
Biostatistics:
Biostatistics is providing the statistical framework essential for designing, conducting, and interpreting clinical trials. Biostatisticians determine sample sizes, develop randomization schemes, and create detailed analysis plans to ensure scientific validity. They meticulously analyze data, interpret results, and contribute to regulatory submissions. This includes study design, data analysis, interpretation of the results, etc.
Medical Function:
The medical function in clinical trials serves as a crucial bridge between scientific data and clinical practice. They provide vital medical expertise throughout the trial lifecycle, from informing study design and patient selection to interpreting results and ensuring ethical data communication. Ultimately, they ensure that the scientific evidence generated is accurate, relevant to healthcare professionals and patients, and supports the safe and effective use of new therapies. It includes overseeing and managing all medical aspects of the clinical trial.
Medics can be in different organisations, sometimes organized by Therapeutic Area or by clinical phase (e.g. Medical Affairs is often a company function supporting Phase IV trials).
The function/department names and exact structures of the departments can be different from company to company. And they are often changed in reorganizations within companies to adapt strategy or optimize processes.