Challenge: A large U.S. manufacturer of medical devices, instrument systems and reagents needed audits conducted at several clinical trial sites.

Beaufort Solution: The client sought assurance that clinical data was valid and could support a PMA submission.  Lacking sufficient internal resources, the client selected Beaufort to conduct the assessments.  Beaufort planned and audited two clinical sites and worked with the client to gain historical information regarding site staff and data collection. Beaufort recommended performing an audit of the sponsor’s trial master file prior to auditing clinical sites, thus ensuring that the sponsor held required regulatory documents for each site.  Beaufort provided audit reports and held subsequent discussions with the client, enabling it to make informed decisions regarding the integrity of data associated with the clinical trial.  The output of these audits provided the client assurance that its required study files were in order for potential FDA inspection following the submission of the PMA.

Date posted: October 27, 2011

Categories: Case Studies Quality Assurance & Compliance