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)