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clinical research

Clinical Research Courses in India

Published On: 24 Aug 2010 | Last Updated On: 04 Jul 2012
The last five years saw a notable growth of clinical research training courses in all parts of India. These institutes are of varied types, some belonging to private entrepreneurs, private companies, universities and trusts. Since there is no national or international standard of education or syllabus, the courses vary in length, content and relevance. The offering by different institutes in terms of certificates of completion differs widely. While most offer a package of what is termed as Clinical Research, some institute offer courses in clinical data management, quality assurance, business development, regulatory affairs, all concerning clinical research only. 
 
Institutes providing clinical research courses
 
Total number of Institutes - 15
Affiliated to Indian Universities - 3
Affiliated to Foreign Universities - 2
Offering Master's Degree - 2
Offering Diploma/certificates - 14
Course other than clinical research - 13
 
Going purely by numbers, there are a large number of institutions involved in clinical research education though the ground reality differs. Presently there are no guidelines for suggest facilities and requirements for clinical research education. If they were to be formulated, most institutes in India would not be found compliant.
 
Let us see some of the courses available in Clinical Research. 
 
Post Graduate Certificate Course in Clinical Research and Clinical Data Management.
 
Objective of the Course - To produce highly skilled manpower in the area of Clinical Research.
 
Course Structure - The course is covered in two modules having total duration of six months. The course has practicals in the form of assignments to be solved by students. In addition students are expected to do a project under a guide from the industry. The course does not include any direct trials/ experimentation on human or animal subjects.
 
Teaching Methodology - The Academic Council of the University approves the syllabi, which is upgraded regularly keeping in mind industry requirements. The syllabi is split into 12 sub-modules covering the areas of Drug Development, Good Clinical Practices, Regulations, Monitoring, Audit, Data Management, Statistics, Pharmacovigilance, Medical Writing and Project Management.
 
Learning outcomes - After completion of course the Participants should be able to have a better understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research and Clinical Data Management and have an understanding of evolving regulatory process standards and practices of ICH GCP in conduct of different therapeutic trials and for preparing the submissions made to the regulatory authorities for seeking market authorization in India, US, EU, Japan etc, to be able to contribute better to the industry.
 
Eligibility - To be eligible for the course one should have at least completed their BSc and have 1 year relevant work experience in the industry/ research institute/hospital or have completed their MBBS / B.D.S / B.A.M.S / B.H.M.S / B.E. / B. Tech/ B. Pharmacy / BVSC/ B.Sc. (Nursing)/ MCA/ MBA/ M.Sc. / M.Pharm/ MA (Maths or Statistics)
 
 
FULL TIME COURSES
 
M.Sc. in Clinical Trials & Drug Development (M.Sc in CT & DD)
 
About the course :
 
This program would be covering topics of Clinical Research, Clinical Trial Management, Pharmacovigilance, Clinical Data Management, Drug Discovery & Development, Ethics, Regulations, Project Management and many more. 
 
Duration:
 
M.Sc. Clinical Trials & Drug Development is a two-year full-time course with lectures held from Monday to Friday.
 
Eligibility:
 
Graduate or Postgraduate in Life Sciences / Microbiology / Biotechnology / Pharmacy / Medicine / Nursing / Physiotherapy / Dentistry / Homeopathy / Ayurvedic and Veterinary Science.
 
 
Advanced Postgraduate Diploma in Clinical Research Management (APGDCRM)
 
About the course :
 
This first-of-its-kind programme in India is comprehensively-structured and internationally-styled to match academic standards with industry requirements. The mix of Clinical Research, Clinical Data Management, Medical Writing and Pharmacovigilance curriculum along with Management Module and Soft Skills in the course ensures a head start to move up the corporate ladder faster. 
 
Duration:
 
APGDCRM is a one-year full-time course with lectures held from Monday to Friday.
 
Eligibility:
 
Graduate or Postgraduate in Life Sciences / Microbiology / Biotechnology / Pharmacy / Medicine / Nursing / Physiotherapy / Dentistry / Homeopathy / Ayurvedic and Veterinary Science.
 
 
PART TIME COURSES
 
Post Graduate Diploma in Clinical Research (PGDCR)
 
About the course:
 
The PGDCR course at is a one year weekend course. It focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of a drug. The course content has been reviewed and approved by Clinical research experts and academicians where more emphasis is laid on Planning, conducting, monitoring and generating information as per global standards and regulatory requirements. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning.
 
Duration:
 
PGDCR is a one year part-time course with lectures held every week.
 
Eligibility:
 
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic and Veterinary Science.
 
Post Graduate Diploma in Clinical Data Management (PGDCDM)
 
About the course:
 
Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials. This one year part-time course is one of the most comprehensive course on the subject. It includes hands-on training on SAS, Data Management, Coding, Database Designing & Validation Procedure Writing. Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. The course is divided into two semesters which comprises both theory and practical sessions having workshops, case study assignments, and exercises. During all practical sessions, the students will get hands-on experience on Clinical Data Management software and its applications like Oracle Clinical and EDC Software.
 
Duration:
 
PGDCDM is a one year part-time course with lectures held every Saturday.
 
Eligibility:
 
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT
 
 
Post Graduate Diploma in Pharmacovigilance (PGDPhV)
 
About the course:
 
Pharmacovigilance in concerned with the development of science and regulation in the area of drug safety. It aims at detection, assessment and prevention of adverse effects and other medication related problems. This one year part time course is designed to impart the knowledge of regulatory requirements of drug safety monitoring for various countries, train the students on management of pharmacovigilance projects in an organization, drug safety data development during pre-clinical and clinical phases of drug development and during post approval period. The PGDPhV course covers entire array of topics that are related to pharmacovigilance: Clinical research and ethics, basics of adverse drug reactions, principles of pharmacovigilance and the regulatory perspectives. In addition, this course is divided into two semesters that comprises of both theory and practical sessions having exercises and clinical case assignments. During practical sessions, the students will get hands on experience on pharmacovigilance databases, information resources, coding systems and their applications.
 
Duration:
 
PGDPhV is a one year part-time course with lectures held every Saturday.
 
Eligibility:
 
Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT.
 
 
Post Graduate Certificate In Clinical Research
 
Have better understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research and Clinical Data Management. 
Contribute more effectively in their profession pharmaceutical/ biopharmaceutical companies in drug development, CROs offering clinical research and clinical data management services, in bio-IT life science industry, or academic research institution or as clinical investigators at hospitals/ medical sites conducting trials on subjects.
Support overall clinical trial process electronically by implementing Electronic Data Capture (EDC) system and Project Monitoring.
Participate in design, conduct and management of global clinical trials conducted at multicentric sites in India and Overseas.
Have an understanding of evolving regulatory process standards and practices of ICH GCP in conduct of different therapeutic trials for preparing the submissions made to the regulatory authorities for seeking market authorization in India, US, EU, Japan etc
 
Course Duration: Post Graduate Certificate course in Clinical Research will be covered in two modules within six months beginning with a foundation in clinical research and followed by data management.  Medium of instruction will be English.
 
 
Career Prospects : Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research organization).Jobs are also available in Biopharmaceutical industry.
 
 
Clinical Research has found a niche reckoning in today's world and is very well recognized and is utilized in various sectors. Here's an overview of some of the opportunities.
 
The Clinical Research courses is useful for: 
 
  • Doctors – Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical Research Physician. 
  • Pharmacists, Life Science graduates, Science postgraduates in Biochemistry- Medical writers, Clinical Research Associate, Site Coordinator, Clinical Research Manager and Drug Development Associate, Biostatistician,Quality assurance
  • Management Graduates (MBA) – Business Development, Clinical Project Management, Clinical Research Management, Regulatory Affair Management. 
  • IT professionals, Biostatistician, Engineers, postgraduates in Maths, Applied Maths, operational Research, Statistics – Clinical Data Manager, Drug Development Associate.
 
Thus we have seen some of the Clinical Research courses, their duration, eligibility and the opportunities they provide along with the scope.
 
Hope this paves the way for more qualified doctors that enrich our country.
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