Executive Certification in Clinical Research Operations and Trial Management

This executive diploma program was designed for pharmacy, life sciences, nursing, medical and allied healthcare professionals seeking structured exposure to clinical research operations. The program provided practical orientation on clinical trial planning, site operations, regulatory documentation, ethics committee coordination, informed consent process, monitoring readiness, safety reporting and inspection-focused trial conduct.

The program emphasized real-world application, site-level responsibilities, sponsor/CRO expectations, documentation discipline and quality-driven conduct of clinical studies.

Key Learning Areas:

Clinical Trial Phases, ICH-GCP, Schedule Y overview, Ethics Committee Submissions, Protocol Interpretation, Informed Consent Process, Source Documentation, Site File Management, CRC/CRA Responsibilities, Monitoring Visits, AE/SAE Reporting, Protocol Deviations, Audit and Inspection Readiness.

Intended Participants:

Pharmacy students, Pharm.D graduates, clinical research aspirants, CRCs, junior CRAs, site staff, life science graduates and healthcare professionals.