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.
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, & clinical research. Even B,Sc life sciences or B.Tech in Biotech are eligible for the course.
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. Thecourse –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.
Mode of Course: - Distance Mode Education
Paper-I: Introduction to Clinical Trials
Paper-II: ICH, Ethics, IRB and Regulations for Clinical Trials
Paper-III: Contract Research in Clinical Trials
Paper-IV: Biostatistics in Clinical Trials
Paper-V: Introduction to Clinical Trials Data Management
Paper-VI: Computerized Systems for E- Case Report Form and Data Acquisition andValidation
Paper-VII: Bioavailability and Bioequivalence Studies
Course Fees: - Rs 10500/-(Indian Student) / 350 USD (Overseas Student)
Study Material for the course: - Complete study material will be provided by the institute in printed book form, PPT and Video Lectures.
Fees Submission: Course fees can be submitted by DD or Cheque in favour of “IBRI- Unit of Exordior Technical Services Pvt Ltd” and payable at “NOIDA”.
Or by NEFT to institute account
Beneficiary Name- IBRI
Beneficiary Account No: - 914020014746404
Bank IFSC Code: - UTIB0000022
Bank Name: - AXIS BANK
Branch Address: - SECTOR 16, NOIDA 201301 (UP)
Keep a photo copy of form and draft and send it by post or courier.
You can also register yourself for the course in person.
Examination and Evaluation Process: - One time examination and mode of examination are
· Assignment Based Examination
· Examination Center based Examination
· Evaluation by experts from industry and academic team of institute.