What is clinical research?

Clinical research is a branch of healthcare science that evaluates the safety and efficacy of drugs, devices, diagnostic tools, and treatment regimens in patients. It is an interdisciplinary field of translational medical science that accelerates the transfer of clinical findings through bench tests, preclinical and clinical trials pivotal for advancement of medical science.

What is Pharmacovigilance?

Pharmacovigilance (PV) is the branch of medical science that deals with set of activities focused on detecting, assessing, storing, understanding, and preventing adverse effects or any other drug-related problems throughout a drug lifecycle. It ensures patient safety by monitoring marketed drugs for side effects, ensuring the benefit-risk ratio remains favorable for patients.

What is clinical data management?

Clinical data management is the process of collecting, cleaning, and managing data from clinical trials to ensure it is accurate, reliable, and compliant with regulatory standards. It transforms patient data obtained from clinical trials into high-quality, analysis-ready information, supporting safety assessments, and effective medical decisions. 

What is evidence-based practice?

Evidence-based practice (EBP) is the diligent, clear, and sensible use of current best evidence from scientific research to make decisions about individual patient care. It integrates top-tier clinical research with clinical expertise and patient values, ensuring treatments are effective, safe, and affordable to the global patients.

What is medical writing?

Medical writing is the specialized process of researching, writing, and editing of accurate scientific documents regarding drugs, devices, and treatment strategies. Medical writers synthesize complex clinical data for wide range of audience, including regulatory bodies, healthcare professionals, and patients, in various formats such as scientific literatures, regulatory submissions, and educational materials.

What is real-world evidence?

Real-world evidence (RWE) is clinical evidence regarding the usage, benefits, and risks of medical products derived from analyzing real-world data (RWD) collected outside traditional clinical trials. It uses data obtained from daily patient care such as electronic health records (EHRs), insurance claims data, and data from wearable devices to evaluate performance of drug or device in diverse real-world population.

Job opportunity in clinical research?

For freshers obtaining a suitable position in various branches of clinical research including clinical data management, pharmacovigilance, and medical writing or regulatory affairs requires fundamental knowledge of standard operating procedures and methods involved in day-to-day work. Every drug manufacturing company and contract research organization (CRO) hire life-science graduate including healthcare professionals for accomplishing responsibilities allocated by regulatory bodies on timely basis.

There is a continuous requirement of replenishing trained candidates in to this field for continuing drug development, which is a never-ending process. To simplify the level of opportunities in drug development, one should understand that the total number of drugs available currently or known to human beings are at least three times less compared to known number of rare diseases. Therefore, life science graduates play an important role in clinical research, as positions cannot be solely fulfilled by hiring healthcare professionals.