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,
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.
Retrospective Data review and Verification, Independent QA visits, Report review, Close out, Pre-Inspection Readiness support, Handling of Regulatory queries.