M.Sc. Clinical Research

Evaluate critical domestic and global regulatory affairs and health care issues that challenge and influence biopharmaceutical product development. Develop a research question, design and plan a clinical research project that complies with industry and government standards and protocols.

Demonstrate the abilities to apply the principles of Pharmacology and Pharmacokinetics
and Pharmacodynamics of the drugs in clinical trials

Demonstrate competency in various biopharmaceutical clinical trial research designs and conduct, and analysis and reporting of a clinical trial and perform appropriate sample size
calculations, randomization, outcome selection and tests of significance.

Demonstrate knowledge the significance of patient and public involvement, and
demonstrate appropriate methods of participant selection in clinical research. Effectively
assess and manage ethical clinical trial programs and biopharmaceutical development
projects

Adhere to the principles of Good Clinical Practice and regulations when designing and
conducting clinical research.

Develop an Informed consent and obtain approval from the Institutional ethics Committee
for the conduct of a clinical research

Demonstrate skills to collect, maintain, critically appraise and interpret the clinical trial
data and communicate effectively.

Demonstrate importance of pharmacovigilance activities and implement a comprehensive
pharmacovigilance reporting system

Apply the principles of quality assurance in all aspects of clinical research

Develop interdisciplinary research collaborations and demonstrate project management
skills needed for successful management of clinical trials.

Forecast the resources necessary for developing and managing biopharmaceutical clinical
research grants and trials as required and regulated by global regulatory agencies.

Effectively communicate and collaborate with health care providers and regulatory
agencies to develop culturally diverse domestic and global strategies for
biopharmaceutical product approvals