Role of clinical research comes very early during the lifespan of a drug. A drug once discovered and stabilized, need to undergo wide number of tests and trials (lab animals and humans) in order to ensure the safety and efficacy of the drug; before making it available for the patients to administer. Technically, clinical research involve carrying out scientific study to understand and assess the effects, risk factors, benefits attached with an investigational drug; by means of undertaking clinical trials. Out of the 4 stages of clinical trial, three of them are carried out before the drug reaches the market, while the fourth stage involves post marketing surveillance to understand its impact on a larger and diverse population of patients. Clinical trials may be conducted by the pharmaceutical industry itself or being outsourced to a CRO (contract research organization), located in a low cost location, such as an Eastern European or Asian country.
Careers in clinical research are available at various levels, with the entry level being that of a clinical research associate. Key roles of an associate range from designing a trial, followed by implementing and monitoring the clinical trial. Other key roles include coordinating with physicians across the trial centers, in order to ensure good clinical practices being followed.
A biostatistician in clinical research comes handy in performing statistical analyses through programming and designing. Key result areas for a biostatistician include analyzing raw data of the trial, planning and performing statistical analyses, and providing study reports on case to case basis. Biostatistician also coordinates in the submission of biological licenses and new drug application licenses with the competent authorities.
Clinical research is one of the most evolving career options, across all domains, and there is a huge dearth of man power in the sector. Basic eligibility required for a career in clinical research includes a graduate degree in life science, pharmacy, biosciences or medicine.