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Advanced PG Diploma in Clinical Research — 6-in-1 Course
Duration: 6 Months | Regular & Weekend Batches | 95% Placement Ratio
Clinical Research Program
PG Diploma in Clinical Research
Ideal job-oriented course for Life Science, Pharmacy & Medical graduates
MODULE 01
Clinical Research Operations
- ICH-GCP Guidelines
- New Drug & Clinical Trials Rules
- TMF / eTMF Management
- Site Management & Monitoring
- Protocol Deviations & AE Reporting
MODULE 02
Clinical Data Management
- Introduction to CDM & Process Flow
- Data Entry & Database Design
- Data Review & Validation
- Essential Documents in CDM
- CDISC Standards Overview
MODULE 03
Pharmacovigilance
- Introduction to Pharmacovigilance
- Eudravigilance System
- Signal Detection & Management
- PSUR Writing
- CIOMS / MedWatch Forms
MODULE 04
Medical Writing
- Introduction to Medical Writing
- Protocol Writing
- Investigator Brochure (IB)
- Informed Consent Document (ICD)
- Manuscript & Publication Writing
MODULE 05
Regulatory Affairs
- Global Regulatory Agencies
- Common Technical Document (CTD)
- CTD for API & Formulation
- Introduction to eCTD
- Drug Approval Processes
MODULE 06
Interpersonal Skills
- Soft Skill Development
- Presentation Skills
- CV Preparation & Writing
- LinkedIn Profile Creation
- Interview Preparation
Eligibility Criteria
MBBS
BDS
BAMS
BHMS
B.Pharm
M.Pharm
B.Sc (Life Sciences)
M.Sc (Life Sciences)
Biotechnology
Nursing
All Available Courses
Clinical Research Courses
Advanced PG Diploma in Clinical Research
6-in-1 ideal job oriented clinical research course for life science, pharmacy and medical graduates.
6 Months
Regular & Weekend Batches
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