Clinical Operations Services A to Z

  • CRO Selection process (Request for Proposals, etc.)
  • Risk Assessment (RACT)
  • Site Selection, Initiation and Activation process
  • CRO Oversight framework and trackers
  • Sponsor Trial Master Files (TMF) implementation in line with DIA model

Training Services

  • ICH Good Clinical Practice (GCP) for Sponsor and Investigators (foundational / refresher)
  • Working with CROs: The Practical Playbook
  • Implementation of Risk Assessment in Clinical Trials
  • Other tailor-made courses with selected partners

Scientific Expertise

  • SOP Gap analysis
  • Clinical Development Plan (CDP) of Clinical Trials programs
  • Due Diligence of Clinical Development Dossiers for investment funds, startups/biotechs, grant awards
  • Inspection Readiness preparation

Internal / External Staffing

  • Clinical Operations: CRAs, CTAs, CPMs
  • Data Manager
  • Biostatistician
  • Medical Monitor

Human Resources

  • Resource Mapping
  • Competency analysis and framework development
  • Soft skills indicators in Clinical Operations and Clinical Development