Trainings
Practical, Regulatory &
Ethics-Focused Training for Clinical Research Professionals.
Build Competence. Strengthen Compliance. Protect Participants.
Clinical research is evolving rapidly, with increasing emphasis on participant safety, data integrity, ethical conduct, regulatory compliance, quality management, and risk-based approaches to clinical trials.
Whether you are new to clinical research or an experienced professional seeking regulatory updates, our programmes are structured to strengthen your knowledge and support
inspection-ready, ethical, and quality-focused research practices.
Our Clinical Research Training Topics
Core programmes covering regulation, ethics, safety and day-to-day site practice.
Good Clinical Practice (GCP)
ICH-GCP – E6(R3)
New Drugs and Clinical Trials Rules, 2019
ICMR Ethical Guidelines
Bioethics in Clinical Research
Roles & Responsibilities of EC Members
Principal Investigator Training
Clinical Research Site Staff Training
Serious Adverse Events (SAEs) & Safety Reporting
Informed Consent Process
Clinical Research Documentation
Regulatory Updates
Additional Training Modules
Our programmes can also cover:
- Clinical Trial Fundamentals
- Clinical Trial Lifecycle
- Clinical Research Methodology
- Monitoring in Clinical Trials
- Risk-Based Monitoring
- Source Data Verification and Review
- Protocol Deviations & Violations
- CAPA and Root Cause Analysis
- Audit Readiness
- Regulatory Inspection Readiness
- Conflict of Interest
- Confidentiality and Data Privacy
-
Research Misconduct and
Research Integrity
Training Formats
We offer flexible training formats to meet institutional and individual requirements:​
Live Online Training
Interactive instructor-led sessions accessible from anywhere.
In-House Institutional Training
Customized programmes conducted specifically for your organization or institution.
Ethics Committee Training
Specialized programmes for new and existing Ethics Committee members.
Classroom Training
Face-to-face programmes for healthcare institutions, universities, hospitals and research organizations.
Workshops & Refresher Programmes
Focused sessions addressing specific clinical-research topics and regulatory updates.
Investigator & Site Staff Training
Role-specific programmes focused on practical site responsibilities and compliance.
Note: Training duration can be tailored from focused half-day workshops to comprehensive multi-day programmes.
Stay Updated with Regulatory Changes
Clinical research regulations and guidance continue to evolve. Our programmes incorporate relevant regulatory developments and updates so that participants can understand how changes may affect their roles and responsibilities.
Who Should Attend?
Our Clinical Research Training programmes are suitable for:
- Principal Investigators
- Clinical Research Associates
- Ethics Committee Members
- Hospital Administrators
-
Institutional Ethics Committee
Coordinators
- Co-Investigators
- Research Nurses
- Ethics Committee Member Secretaries
- Medical and Dental Professionals
- Biotechnology and Life-Science Professionals
- Clinical Research Coordinators
- Site Research Staff
- Academic Researchers
- Pharmacy Professionals
- Professionals entering the clinical-research field
Enroll for Clinical Research Training
Whether you are an investigator, Ethics Committee member, clinical research professional, healthcare professional, researcher or institution, our training programmes can help you develop practical competence in ethical and regulatory clinical research.
Contact us to discuss your training requirements and develop a programme suited to your organization or professional role.
Our Clinical Research Training Topics
Eleven core programmes covering regulation, ethics, safety and day-to-day site practice.
Good Clinical Practice (GCP)
Understand the fundamental principles of GCP and their application throughout the clinical-trial lifecycle.
ICH-GCP – E6(R3)
Comprehensive training on the current ICH E6(R3) Good Clinical Practice framework, including its principles and practical application.
ICH E6(R3) was adopted at Step 4 on 6 January 2025, and its updated framework emphasizes flexible, risk-proportionate approaches while maintaining participant protection and reliable trial results.
New Drugs and Clinical Trials Rules, 2019
Practical orientation to India's regulatory framework governing new drugs and clinical trials.
The CDSCO maintains the NDCTR 2019 framework together with subsequent amendments and notifications, making regulatory-update training particularly important for clinical-research professionals.
ICMR Ethical Guidelines
Training on the ethical principles governing biomedical and health research involving human participants in India.
Bioethics in Clinical Research
Develop a strong understanding of the ethical foundation of human-participant research.
Roles & Responsibilities of Ethics Committee Members
A dedicated programme for Institutional Ethics Committee members, Member Secretaries, Chairpersons and administrative staff.
CDSCO describes Ethics Committees as responsible for ethical review and oversight, including review of informed consent, participant recruitment, and applicable compensation matters.
Principal Investigator Training
Strengthen investigators' understanding of their responsibilities from study initiation through study closure.
Clinical Research Site Staff Training
Practical training for clinical research coordinators, site coordinators, research nurses, data-management personnel and other site staff.
Serious Adverse Events (SAEs) & Safety Reporting
Understand the identification, documentation, assessment and reporting of serious adverse events.
India's CDSCO maintains a dedicated SAE regulatory process under NDCTR 2019, including review of SAE-relatedness and compensation matters.
Informed Consent Process
Practical training on obtaining, documenting and maintaining valid informed consent.
Clinical Research Documentation
"If it isn't documented, it is difficult to demonstrate that it happened."
Training focuses on accurate, complete, contemporaneous and traceable clinical-trial documentation.