Budget development, site fees and contract negotiation, payment of investigator fees
Investigator site selection
Feasibility
Pre-study site visits
Compilation of local and central ethics submissions
Compilation and submission of regulatory files
Initiation visits
Investigator meetings
Site monitoring
Close-out
Outsourcing of Clinical Research Professionals:
Bespoke CRA team creation
Individual CRAs
Managed CRAs
Other Services:
Bespoke training courses
Medical monitoring and drug safety
Quality Assurance
Managed:
Identification, negotiation and integration of data management, IVRS, drug warehousing, eCRF implementation, central laboratories, medical writing and other services into core offerings
