GCP Auditing

Compliance with Good Clinical Practice (GCP) is critical in ensuring that organization will avoid expensive delays. Our experts apply industry and regulatory agency experience in ensuring compliance with all aspects of designing and executing a successful clinical trial including:

  • Establishment of an audit program including the review, creation and updating of your Standard Operating Procedures (SOPs)
  • Development of tools and templates for auditing clinical sites, CROs, clinical data, and internal clinical files
  • Creation of a GCP training program that allows your team to develop skills to manage audits autonomously
  • Trend analysis of clinical data
  • Documentation of audit report findings and
  • Review of informed consent requirements and HIPPA privacy regulations

Audit Programs

Our consultants will work with your team to develop an audit program that supplements or serves in place of your internal capabilities. We have expertise in designing audit programs for early stage clinical trials through post-commercialization. Our programs are designed to address the following areas:

Document Review

  • Reveiw of informed consent documents and ensure compliance with HIPPA regulations
  • Case Report Form (CRF) review
  • SOP development and review

Database and Trial Master File Audits

  • Computer Systems Validation (CSV) audits
  • 21 CFR part 11 compliance review
  • Database audits
  • Trial Master File audits

Site Audits

  • Phase I unit audits
  • Investigator sites
  • CROs
  • Clinical laboratories/pharmacies