With an aim to meet the acute shortage of trained and skilled manpower faced by the clinical trial industry in the country, the School of Public Health under SRM University in Chennai is starting a university level PG course in clinical trials from July this year.

According to information received from the university, this course is the first university approved PG Programme on clinical trials conducted by a university in the country. The classes will commence in July this year and the admission process will start from February. The fee for the two-year programme is Rs.2 lakhs.

Graduates in medicine, pharmacy, dentistry, Indian systems of medicine, life sciences and other paramedical branches are eligible to seek admission for the new PG Programme. A selection test will be conducted along with an interview to test the student’s aptitude, domain skills, subject wise knowledge and communication. Admission to the program would be based on selection test scores, previous academic records/scores and relevant work experience, if any, said Prof R Kamaraj, head of the department.

He said  the course aims to provide students with theoretical and practical understanding in designing, conducting and managing clinical trials. The core skills developed are in the areas of biostatistics, medical writing, regulatory affairs, clinical data management, pharmacovigilance and epidemiology. The course will help the students to deepen their conceptual and practical skills needed for pharma/biotech, clinical research organization (CRO) and IT industry.

“This is a two-year professional masters degree programme which comprises of four semesters. The course strikes a balance between academics and practice with classes being conducted by academic and industrial experts. The students undertake six month internship at pharma/biotech industry and clinical research organizations as part of the course,” he told Pharmabiz.

The core modules of the course for the first and the second semesters will include basic life sciences, clinical pharmacology, principles and fundamentals of clinical epidemiology, drug discovery and development, designing of clinical trials in clinical research, biostatistics, pharma regulatory affairs, clinical data management (CDM), clinical trials-project management, quality assurance and quality control, ethics in clinical trials and medical writing. The practical course will include visits to pharma industry, biotech industry and CROs.

Semester three and four will include pharmacovigilance-I, pharmacovigilance-II, clinical trials, economics, communication skills and software application (SAS, Oracle Clinical, Medra-AER). Visits to pharma industry, biotech industry and  CROs are held in the second year also.

Regarding the job opportunities, Prof Kamaraj said the School of Public Health has a placement cell attached to it. The cell is tied up with NGO’s, CRO’s, pharma, biotech and IT industries which will provide employment assistances and industry experience to the students.