Challenge: The diagnostics division of a global top 15 pharmaceutical company engaged Beaufort to review its clinical trial protocol and to develop more cost-effective and efficient methods for managing its clinical trials.
Beaufort Solution: This was this division’s first use of an outside vendor to manage clinical trials in support of an FDA submission. Working closely with the client to obtain a full understanding of its processes, Beaufort created systems to manage the trials, combining the client’s operational procedures with our suggestions for system improvements. Clinical trial management included site and investigator qualification, IRB submissions, training, and site monitoring. Beaufort served as a conduit between the sponsors and the clinical sites during the trial for communications and trouble-shooting to ensure necessary processes, documentation, and data collection were in compliance with GCPs.