(Full Time ONLINE)

Course objective: 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 of the course:

• Live interactive weekdays – 2.5 months regular program
• This includes conceptual learnings, development of skills, interview & communication practices followed by placements too.

Course Timings and Schedule: 2 hours live online training, scheduled on Mon- Fri

Eligibility

• M.B.B.S, M.D, M.S, D.N.B, D.M (Interns are also eligible)
• B.D.S, M.D.S, B.P.T, B.Tech (Biotechnology)
• B.A.M.S, B.H.M.S, B.U.M.S
• B.Pharm, M.Pharm, Ph.D
• B.Sc, M.Sc, Ph.D (Final year students are also eligible)
• Working Professionals

Course Content:

Module	Topics
Module 1	– Introduction to Clinical Research. Drug discovery & Development – Basics of Pharmacology and pharmacy, Preclinical Research- GLP & GMP
Module 2	– Regulatory Affairs/ Regulations in Clinical Research – Introduction to Intellectual property rights
Module 3	– Clinical Research Operations – Ethics in clinical research
Module 4	– Clinical Data Management-Designing of Clinical Trials and Biostatistics
Module 5	– CRO, SMO, Clinical trial documents – QA and QC – Audits and Inspections
Module 6	– Pharmacovigilance, Medical writing & Drug Safety Monitoring
Module 7	– Soft skills training, Business communication and AI -IT applications
Module 8	– Research writing and presentation

Online live teaching by eminent faculty involving Lectures and Power Point Presentations.

Assignments are given to students, which include preparation of CRF’s (Case Record Forms), IC (Informed Consent Forms), PIs (Patient Information Sheets), Protocol Designing, PMS (Post Marketing Surveillance Studies) plan designing.

Exercises are given to students wherein develop regular readings on various research articles on human anatomy physiology, toxicology, drug development processes, bioequivalence, and bioavailability is made available to the students and inferences, graphs and calculations are drawn from the same. Exercises are also in the form of surprise tests, Q&A (questions and answers) and Report writing.

Assignments are conducted for students emphasizing on communication through interaction and exchange of information.

Note:

• Detailed Syllabus for each module will be provided along with the course material
• To avail certificate & placement services, required to meet course passing marks criteria

* “Fees (Registration & program fees) once paid will not be refundable”