CLINICAL INVESTIGATIONS & PMCF STUDIES

CLINICAL INVESTIGATIONS & PMCF STUDIES

APC SUPPORTS YOU IN CLINICAL INVESTIGATIONS AND PMCF STUDIES

CLINICAL INVESTIGATION - FULL SERVICE FROM START TO COMPLETION OR SELECTED SERVICE

  • Project Management: Footprint in Clinical Investigation Planning and management of Ethics Committees and Regulatory Authorities, Management of Quality, Timelines and Budget, Contract management, …
  • Clinical investigation Planning: Biostatistical Support, Protocol Development, CRF, Center Identification (Feasibility), Contracting, Renumeration, …
  • Ethics Committee & Regulatory Authorities: Taking Control of the Regulatory Process: EC Approval, Announcement to Authorities…
  • Clinical Investigation Conduct: Qualification Visit, Initiation Visits, Regular Monitoring (remote, risk-based, …), Study Centre Management, Close-out Visits, …
  • Data Management: CRF or EDC, Database set-up, Data Integrity and Quality Checks, Query Management, Final Data Cleaning, …
  • Biostatistics: SAS Programming, TLFs, integrated statistical Report, …
  • Medical Writing: Footprint in Clinical Investigation Planning, Reports according to GCP, Informed Consent Form Development, integrated Investigations Report, …
  • Safety Management: Management of all Study Events (SAE, SUSAR,…)