Selected Auditing Services

Lucid was tasked to perform an audit of a contract facility that had a long history of performing contract work for our client’s studies. 

We were tasked to perform a complete audit, beginning with the general facilities, equipment, personnel qualifications, quality assurance unit, and animal handling portions. 

A study was then chosen at random, and our auditors physically observed every portion of the study performed at that facility.  This included animal preparation, dosing and the collection of blood at every timepoint during the 12-week study. 

Finally, we audited the storage and transfer of samples and the final report provided by the contractor.  We issued a Final Audit Report which served as documentation of the scope and outcome of the audit.

●  We were tasked to perform a thorough and formal audit of a non-clinical research organization, which our client had used for a very long time for a variety of studies.

●  Lucid performed a Facility Audit to verify compliance of the facility, equipment and personnel.

●  We also performed a Technical Audit of a recently completed study to determine the accuracy and compliance of the final analytical report.

●  Our auditors observed all phases of the study within that facility.  That included the collection, storage and transfer of all blood samples.  This included the early collections right after dosing, which required our auditors to be present for 24 hours at a time.

●  Our Final Audit Report was used by our client to document the study being observed, and also to make inferences about previously performed studies that had not been observed.