Post Graduate Diploma in
Clinical Research &
Management
A comprehensive, industry-designed program that prepares you for a successful career in clinical research, pharmacovigilance, medical writing, and regulatory affairs — with 100% placement assistance.
Your Gateway to the Clinical Research Industry
The Post Graduate Diploma in Clinical Research & Management is a 4-month, job-focused program designed for life science and pharma graduates who want to build a rewarding career in the CRO and pharma industry.
Our curriculum is designed by industry veterans with real-world experience, ensuring that every topic you learn is directly applicable to your job from day one. With live training, case studies, and internship opportunities, you graduate as a confident, industry-ready professional.
Comprehensive Course Modules
A structured, step-by-step curriculum covering all key areas of clinical research — from fundamentals to advanced industry practices.
Introduction to Clinical Research
- Overview of Drug Development Process
- ICH-GCP Guidelines & Regulations
- Phases of Clinical Trials (I–IV)
- Roles & Responsibilities in Clinical Research
- Ethical Considerations & Patient Safety
Clinical Trial Management
- Protocol Design & Review
- Site Initiation, Monitoring & Closeout
- Investigator & Site Management
- CTMS and eTMF Systems
- Risk-Based Monitoring (RBM)
Clinical Data Management
- Data Collection & CRF Design
- Electronic Data Capture (EDC) Tools
- Data Validation & Cleaning
- Database Lock Procedures
- CDISC Standards (CDASH, SDTM, ADaM)
Pharmacovigilance & Drug Safety
- Basics of Pharmacovigilance
- Adverse Event Reporting (SAE, SUSAR)
- Signal Detection & Risk Management
- ICSRs and Periodic Safety Reports
- Global PV Regulations (FDA, EMA, CDSCO)
Medical Writing
- Clinical Study Reports (CSR)
- Regulatory Submission Documents
- Investigator Brochures & IB Writing
- Scientific Writing Standards (ICH E3)
- SOPs & Protocol Writing
Career Development & Soft Skills
- Professional Resume & CV Building
- LinkedIn Profile Optimization
- Mock Interviews & GD Sessions
- Email Etiquette & Communication Skills
- Industry Networking Strategies
Kickstart Your Career in Clinical Research
We provide 100% placement assistance to our students, connecting you with top CROs and Pharmaceutical companies in Pune and across India.
Common Questions
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