Pivotal Phase III trial undergoes audits by the FDA and sponsor

Pivotal Phase III trial undergoes audits by the FDA and sponsor

June 1, 2018

Challenge:

A pivotal Phase III clinical trial of C1 inhibitor for the prophylactic treatment of hereditary angioedema managed by ARG successfully underwent 3 investigative site audits by the FDA and a complete audit by our sponsor. The BLA submission for C1 inhibitor has been made to the FDA and approval was granted in 2008.

Results:

ARG’s collaborative team approach to Clinical Trial Management – along with TrialVista®, our industry–leading CTMS solution – helps small and mid–sized biotech companies ensure that what must go right, does go right, and that what can go wrong, doesn’t. The successful outcomes of this approach are exemplified by the following client interactions.

No major findings were noted by the FDA auditors relative to study management, subject medical records, case report forms (CRFs) or regulatory documentation. ARG’s project manager and clinical research associates demonstrated excellent quality and process control, within predetermined budget and scheduling parameters.

ARG utilized its experienced staff and TrialVista®, the company’s Clinical Trial Management System (CTMS), to efficiently manage the successful completion of the clinical trial.

Lessons Learned:

Obtaining good clinical data from investigative sites is only achieved by having the best-trained, highly motivated and dedicated staff that put a focus on relationship building. ARG’s clinical teams are thoroughly prepared for regulatory inspections and every member of our project management staff understands that the value of our results is only as good as the data that harvested at our clinical sites. Every project ARG takes on is with the understanding that it must meet all regulatory requirements and must pass our internal compliance checks to ensure success. TrialVista® is the only CTMS entirely designed and developed by clinical research professionals. It operates using proven technology on a highly secure platform. This translates into a system that works how clinical researchers work, with less downtime and no more worrying about lost or compromised data. TrialVista® is 100% modular and completely customizable. Each module can be rapidly tailored to suit the individual needs of the sponsor as well as each individual study, no matter how small. Implementation is rapid and data is available in this system as soon as it is entered. All authorized users – from the sponsor, site, CRO and vendors – have access to up-to-date information, which eliminates concerns about the regulatory status of a problem site, or how much drug is in inventory.