GCP QA and QC Compliance Audits

RESQ is asked to conduct GCP compliance oversight and evaluations of Clinical Trial functions prior to, during, and post program execution.  Master Audit Plans and Agenda are developed and executed to help ensure Clinical Trial activities progress according to Regulatory Statutes, Protocol Design, and within the Client’s Corporate Policy and Procedural specifications.

We can perform:

  • Development of audit plans and audit forms.
  • Vendor qualification audits.
  • At study start-up: Protocol audits, Case Report Form audits, and Study Progress Notes audits.
  • EDC Screen audits to ensure compliance with protocol and comprehensive study data collection.
  • Internal operations compliance and targeted audits of systems (e.g. data management and clinical operations).
  • Periodic independent audits of other CROs and FSPs on behalf of the Sponsor.
  • Clinical Database audits.
  • Clinical Study Report audits.
  • Standard Operating Procedures (SOPs) audits.
  • Staff training program reviews.
  • Sample or total Investigator Site (compliance) audits on a scheduled or as-directed basis.
  • Deliverables and study components (e.g. Trial Master Files) audits.