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Arbour Group provides clinical audit services for life sciences companies utilizing CROs. A CRO audit ensures the client that the CRO has implemented quality assurance and controls, as integrity of trial data always resides with the sponsor.

CRO Audits include:

  • Internal audits of clinical projects for SOP and regulatory compliance
  • Ensure documentation of deviations from company SOPs and implementation of corrective and preventative action plan as needed
  • Ensure regulatory compliance of laboratories, vendors and clinical sites during the performance of trials
  • Review of clinical project documents including, but not limited to, regulatory documents such as protocols, investigator's brochures and case report forms (CRFs) for quality assurance
  • Audit regulatory documents from clinical sites for compliance
  • Audit potential vendors, central laboratories and warehouse/distribution centers for regulatory compliance (e.g. GCP, GLP and GDP) and ability to meet task orders

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.

 

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