Clinical Trials
CLINICAL TRIALS, REGULATIONS AND DATA MANAGEMENT
Course Overview
Conventional curative proceedings encompass medical professionals to determine remedy on the basis of the former attainments by self or others leading to the finest forecast of the likely course of a disease or ailment. There are concerns on that therapy is entirely persuasive and better room for promising amendments are determined with the help of Clinical Trials, which is cutting-edge operation in medicine and pharmaceutical research. Clinical Trial is a rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use.
| S.NO | Program | Fees (Indian / Overseas) | |
|---|---|---|---|
| 1. | Professional Designation in Clinical Trials and Ethics [3 Months] | Rs.9000/ $550 | |
| 2. | Certificate Course in Medical and Scientific Documentation Writing [6 Months] | Rs.13,000/ $750 | |
| 3. | Certificate Course in Clinical Trials and Contract Research [6 Months] | Rs.13,000/ $750 | |
| 4. | Certificate Course in Clinical Trials Data Management[6 Months] | Rs.13,000/ $750 | |
| 5. | Comprehensive Program in Clinical Trials, Regulations and Data Management [12 Months] | Rs.18,000/ $850 | |
| 6. | Course Structure:For Above Courses | ||
| 7. | Registration Fees | Rs.500/- | |
| 8. | Exam Fees For 3M,6M and 12M | Rs.500,1000 and 1500 | |
Eligibility
Candidates with MBBS / B.D.S / B.A.M.S / B.H.M.S /B. Pharmacy / BVSC/ B.Sc. (Nursing)/ M.Pharma 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.
Course Features
The course curriculum includes all the recent trends and regulations for the planning and conduction of Clinical Trials i.e. ICH, Ethics, IRB and Regulations for Clinical Trials. The course –papers like Design - Randomization, trial size, data monitoring, and 'alternative' designs, Analysis and reporting is characteristic feature of IBRI’s course structure. The self –instructional material is explained with examples so that the students can understand easily.
The institute has introduced courses on Data Management and Documentation in Clinical Trials i.e. Medical Writing in Clinical Trials. The course contents cover Overview of Clinical Data Management in the Regulatory and Quality Context, CDM Personnel Component, Computerized Systems, Developing Case Report Form, Development of CDM Plan and Database Design, CRF Receipt, Data Entry and QC of Data Entry, Data Verification, Data Validation, Database Lock, Transfer and Exporting, Aspects Related to MedDRA Coding and CDM, CDM Report, Listings, Tables, Figures and Statistical Analysis.
Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly. As per the demand of Medical Writers IBRI has introduced the Certificate Course in Medical and Scientific Documentation Writing.
Note:
1-Exam fees are excluded from Course fees.
2-Course fees can be paid by Demand Draft(DD) / At Par Cheque / Cash in favor of "IBRI-UNIT OF EXORDIOR TECHNICAL SERVICES PRIVATE LIMITED" payable at "NOIDA".