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Case Study

FSP Consulting Support – Ongoing Drug Safety Consulting

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A large biotech located in California with dozens of ongoing clinical trials in each of their therapeutic focused areas.

Key Issues:

Due to the complex products our client was developing, they looked to find the best talent possible to support their Drug Safety program. This client needed specialized support for Safety Physicians (Product Leads and Medical Reviewers), PV Scientists, Drug Safety Specialist and other specific needs. Using FTEs for this support made it difficult to move individuals around to different projects or scale up or down if possible. The client preferred to keep this work in house and avoid losing control to a CRO, so they searched for a model that offered reliable long term expertise that could pivot with the changes with the company. Their subsidiaries also needed similar support as they navigated through their relationships with CROs or integrating with the sponsor company.


The partnership with BioPoint offered an opportunity to have versatility with their workforce that acted as an extension of their current team, while also providing accountability and governance to their internal team. BioPoint and the client held periodic governance meetings to which helped to map out the expectations, performance and responsibilities of the BioPoint team. During these meetings, a training schedule was determined to help deem each individual fit to perform their responsibilities, then they were deployed. As they began their work, we analyzed data around the findings of each case that was reviewed.

Since the BioPoint in this case was acting as an extension of the clients existing Safety team, it was possible to easily assess the number of cases reviewed, in how much time, and the overall and individual findings in the cases. This data was compared to the clients team and each time, the BioPoint was within a negligible margin of error and often yielding better results.


Over the course of nearly a decade, BioPoint supported this client with nearly 50 Drug Safety professionals, many of them serving for more than several years. By over-communicating and focusing on delivering quality professionals, BioPoint was able to successfully marry our services with the needs of our client. For a larger company, they needed a partner they could trust and who will pick up the phone when changes arise. Acting as an extension of the existing team, BioPoint seamlessly filled gaps and helped to de-escalate moments of crisis.