
Phase I to III Clinical Trials
Phase-IV (PMS) Interventional & Observational Studies
STUDY STARTUP
- Protocol Design
- Statistical Analysis Plan
- CRF Design
- Investigator Feasibility /selection
- Financial Aspects
- Regulatory Management
- IT Systems (CTMS)
- Document Management (QMS-9001 & ICH-GCP)
- Training (GCP, Protocol, Safety, SOPs)
STUDY CONDUCT
- Protocol Compliance
- Protocol Deviations
- Protocol Amendments
- Subject Recruitment
- Data Entry
- IMP Management
- Investigator Oversight
- Trial Master Files maintenance
- MONITORING
- Safety – AE reporting
- Interim Analysis
- QA, QC, Audit
STUDY COMPLETION
- Protocol DATA Review
- Study Oversight
- Study Closeout
- Data Reconciliation
- Safety Review
- IMP retrieval /destruction
- QA, QC, Audit
- Archiving
SUBMISSION
- Benefit / Risk analysis
- Endpoint Evaluations
- Data reviews
- More extensive document/data reviews
- Clinical Study reports
- Regulatory requirements – Global, local country (DRAP)