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
Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner.
The use of Arbour’s validation product greatly facilitated the process.
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers.
Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation.
Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.