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