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Indian Biosciences and Research Institute

Clinical Trials Data Management and Medical Writing

Clinical trials are systematic investigations in human subjects intended to gather safety and efficacy data of a new drug. The clinical trials conducted all over the world follow universally accepted guidelines and regulations. These trials for new drugs are conducted on human subjects or patients only after abundant satisfactory information has been collected on its quality and safety through pre-clinical or animal studies and which have an approval from the required health and ethical authorities.

     With a reputation for high-quality, cost-effective global clinical trials, Asia are fast becoming the hub for global clinical research. As the clinical trials market continues to expand, the lack of trained professionals and gaps in skill advancement need to be addressed to utilize the huge clinical research potential in the region IBRI has introduced the courses in Clinical Trials with an aim to bridge this 'Knowledge divide'. IBRI mission is to strengthen the clinical research capabilities in Asia by providing effective and cutting-edge educational and training programs in various aspects of clinical research. The institute fosters interactions with experts from industry, government and academic institutes to provide guidance in the development and implementation of training programs.

‘Quality Education of Global Dimensions Leading to
                         Grooming of Professionals for Pharma Industry’

Course Structure

Course Paper Content
Paper:I Clinical Trials, ICH, Ethics, IRB and Regulations for Clinical Trials
Paper:II Clinical Trials Data Management, Computerized Systems for E- Case Report Form and Data Acquisition and Validation
Paper:III Biostatistics, SAS and Data Management
Paper:IV Basics of Good Medical Writing
Paper:V Practical and Project

Course Objectives

Our program aims at realizing the following objectives:

• Give in-depth knowledge in both the theoretical and practical aspects of clinical research, regulatory affairs and clinical data management in the clinical research industry.
• To provide the requisite knowledge by conducting clinical trials which is crucial to attain success in the clinical research industry.


Candidates with MBBS / B.D.S / B.A.M.S / B.H.M.S /B. Pharmacy / BVSC/ B.Sc. (Nursing)/ M.Pharma/Appearing are eligible. Educational qualification and experience in the field of medical sciences, life sciences, data management, and clinical research. Even B,Sc life sciences or B.Tech in Biotech are eligible for the course.


Registration Fees: Rs.1000/- Only

Course Fees: Rs.45,000/- Only(One time payment)
      (Fees can also paid in three installments i.e. Rs.15, 000/ for each installment.


1-Exam fees are excluded from Course fees.

2-Payment is to be made through Cash / Demand Draft / At Par Cheque in favor of "Indian Biosciences and Research Institute" payable at "Noida/New Delhi".

For Further Details Contact:

Indian Biological Sciences and Research Institute
C-50, First Floor, Sec-2, NOIDA-201301(U.P)
Mob:+91-9999 509892
Tel: +91(120)412 2315


Registration Form
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