Situation Synopsis:
A biopharmaceutical company that develops therapies to treat blood-related cancers, was faced with an urgent need to complete a series of audits of the client’s numerous clinical trial sites and manufacturing facilities. The client had to complete over 70 audits of sites located domestically and internationally in a relatively short window of time. The time of year also compounded the difficultly as many of the audits were to be completed prior to the holidays and facility shut downs.
Challenges:
The client’s rapidly progressing pipeline products posed an internal challenge as products advanced into various phases of clinical development and preparation for commercial manufacturing was underway. Numerous new and existing CRO and CMO sites needed to be audited to support the amount of activity created by the advancement of the promising drug candidates. The bulk of the clinical sites were in various European Union countries and the U.S. sites spread across the country, creating another logistical challenge. The aggressive timelines further added to the difficulties and the client realized that they needed an external partner that would supply them with a solid solution to deliver proven results.
Actions:
Black Diamond Networks (BDN) reacted quickly to put an action plan into place that would work for the company and ensure both the audit schedule was met and the diverse needs of the various facilities were addressed by subject matter experts in those areas. BDN assembled a team that consisted of an audit leader, two ex-FDA auditors, an Oncology study specialist, and other certified auditors with various GMP and GCP expertise. In addition, BDN supplied the client with an audit coordinator to schedule, track, and manage the various audit requirements. By utilizing a team of ten auditors, Black Diamond Networks was able to continually monitor and re-assign auditors to ensure multiple audits could be performed in various locations at the same time.
Results:
The client was able to successfully complete the entire audit schedule within the planned period of time. This afforded the client with enough time to address the issues and compliance gaps found during the audits and ensure that steps could be taken to minimize risk and assure the quality of their clinical and manufacturing operations. Moreover, the client had developed a trusted partner that could be relied on to handle future unexpected audit related needs and enable the client to press forward with future business initiatives.
