The Bio-informatics and Clinical Research Group of the AU-KBC Research Centre of Anna University, Chennai (K BChandrasekhar Research Centre) is offering an exclusive Post Graduate Certificate Course in Clinical Trial Management (CTM) from June this year at the University's MIT Chromepet Campus.

The four-month Full Time Certificate Course, with a total of over 500 hours of lectures and practical classes, will formally commence on June 12. The university plans to offer this course three times a year and there is a proposal to start the part-time course also.

According to the information received from the institute, the Research Centre is starting this course to meet the acute shortage of trained and skilled manpower to work as Clinical Research Associates (CRAs) for the conduct of clinical trials as per international standards. There were reports of acute shortage of skilled and trained manpower in the clinical trial industry as India is becoming an international hub of clinical trial industry due to several factors.

Students with MBBS, BIM, BHMS, BDS, B. Pharm and Degree in Life Sciences like Biotechnology and Paramedical branches will be eligible to seek admission in the course. They will have to clear a written test and an interview, and initially, 35-40 students will be admitted in the course in the first phase, sources said.

The Research Centre has designed the Course Curriculum and is engaging doctors and scientists from Medical Colleges, Hospitals, CROs, Pharma companies, Research Institutions and Universities as specialist faculty members to teach the course.

On successful completion of the course, the students will be able to find employment as Clinical Trial Associates, Clinical Research Coordinators in leading Pharma companies and CRO firms, Support staff for Investigators, Hospitals, Surveillance staff for sponsors, Bio-Statistical Services to various clients involved with clinical trials, Regulatory and Drug Control Agencies, Training faculty, etc.

While topics in Drug Discovery and Development process necessary to understand the importance of clinical trials, the specific objective of the training program itself is to train candidates to support and manage clinical trials, as explained the officers. Regarding the course structure, about half the time would be for class room lectures by the course faculty, and the rest for lab classes, demonstrations, seminars, visits to hospitals, CROs, and research labs.

According to a Mckinsey report, Clinical Trials industry in India is projected to be worth about a billion US Dollars and needing about 50,000 trained people by 2010. Quality of trained manpower available to it will be a key element for the success of this industry in leveraging the many advantages our country has in the Clinical Trials area, such as availability of large patient populations with diverse disease conditions, large variations in cultural and dietary habits, skilled clinical investigators and adequate analytical facilities and resources, a modern regulatory and legal framework with competent professionals, a much lower cost structure compared to the industrially advanced nations, etc.