Project Management involve end to end services which start from Site Identification, Feasibility, Audit and Selection through budget finalisation, Protocol Review, Complete coordination and Monitoring of Study from Start to end till Final Close out and report submission. various stages have been given below,
Pre-Study:
Site/CRO Identification, Feasibility, Audit, Selection and Study Budget Finalisation, Protocol writing and review support, Selection of appropriate design of the study, Regulatory insight, Controlled correspondence with regulatory, Complete Pre-Approval Support,
During Study:
Complete Coordination with CRO/Site personnel. Timeline Management and Slotting, IMP Accountability verification, Complete Project Management of entire trial, Complete Monitoring with Scope agreed upon with Client. Risk-Mitigation plan assessment.
Post Study:
Retrospective Data review and Verification, Independent QA visits, Report review, Close out, Pre-Inspection Readiness support, Handling of Regulatory queries.