A comprehensive programme integrating scientific concepts with regulatory, ethical, and practical applications across the full clinical trials ecosystem.
The PG Diploma in Clinical Research provides a comprehensive understanding of the clinical research ecosystem — integrating scientific concepts with regulatory, ethical, and practical applications.
This programme equips learners with the knowledge and skills required to excel in clinical trials, data management, safety monitoring, and regulatory compliance — across 16 in-depth modules covering everything from foundational concepts to emerging technologies.
16 comprehensive modules covering the full clinical research lifecycle
Covers national and international regulatory frameworks including CDSCO, USFDA, and EMA
Includes emerging technologies — AI/ML, virtual trials, and remote monitoring
Updated with 2019–2024 regulatory revisions including ICH GCP E6 R3 and NDCT Rules
16 progressive modules from foundational concepts to advanced industry applications
Industry landscape, historical development, and core terminologies
Landmark milestones and the evolution of ethical frameworks
Key ethical principles and global regulatory standards
How global regulators influence clinical research practices
From Investigators and Sponsors to CROs, CRCs, and CRAs
Analytical skills, hypothesis testing, and scientific writing
Study designs and their real-world applications
Essential documentation throughout a clinical trial
Electronic data handling, eCRF systems, and good documentation practices
Drug safety, ADR, SAE reporting, and risk management
Quality systems, audits, inspections, and common observations
Device-specific regulations, classification, and trial phases
Clinical documentation from case reports to CSRs
AI, ML, digital tools, and remote patient monitoring
Latest regulatory revisions and compliance updates
Real-world challenges and solutions in clinical research settings
Understanding how major global regulators shape clinical research
CDSCO
Central Drugs Standard Control Organisation, India
ICMR
Indian Council of Medical Research, India
USFDA
U.S. Food & Drug Administration, USA
EMA
European Medicines Agency, Europe
MHRA
Medicines & Healthcare products Regulatory Agency, UK
TGA
Therapeutic Goods Administration, Australia
Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma, and Professional Certification Programmes.
Programme Duration
6 Months to 1 Year
Minimum 6 months · Maximum 12 months
Programme Mode
Online Mode — Registrations Open
Programmes Available
PG Diploma · Executive Diploma · Professional Certification
Programme Fee
Full Time / Part Time · Online Live Classes
or $598 USD