Life Sciences Diligence Firm to Ensure Compliance, Data Integrity in Clinical Trials

A portfolio company was venturing into a deal within clinical trial sites. These sites had a significant amount of data to collect and report back to pharmaceutical companies or contract research organizations (CROs). The company needed a service provider to validate that each site was operationally conducting studies correctly, ensuring compliance and data integrity.

The portfolio company didn’t have a preferred vendor for this specific need. The challenge was to find a service provider with a deep understanding of the FDA compliance requirements and the demands of pharmaceutical and CRO customers. Moreover, the company was on a tight schedule, aiming for a kick-off within three weeks for a 1-2 week engagement.

BluWave leveraged its extensive network to identify two life sciences data diligence firms within a single business day. The selected firm between the two had a team primarily consisting of ex-FDA professionals, boasting years of experience in the field. They had a track record of conducting numerous audits within clinical trials, ensuring compliance and data integrity. By understanding the portfolio company’s unique needs and the intricacies of clinical trials, BluWave facilitated a tailored connection, ensuring the client was introduced to the most suitable service provider, and fast.

The life sciences data diligence firm proposed a comprehensive audit, focusing on the electronic database capturing system and the trial master file. Their expertise and approach ensured that the portfolio company would receive a thorough assessment of the clinical trial sites, ensuring operational compliance and data integrity. The engagement not only met the company’s budgetary constraints but also aligned perfectly with their tight timeline, positioning them for success in their clinical trials venture.