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Case Study

Pharmacovigilance Operations: Project-Based FSP Support

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A large biotech located in the San Francisco Bay Area with a variety of products across all phases and therapeutic areas. 

Key Issues:

Our client received word from the FDA that their partial clinical hold on their studies for oncology products in Phase 2 and 3. They were then pressed to have several hundred safety narratives to be written and QC’d within a two to three month timeframe. Due to the complexity of the cases and the timelines and deliverables being so fluid, our client was in need of a partner who could act quickly, remain flexible all while delivering quality results. 


BioPoint had in this case two engagement managers supporting the client. We assess initial deliverables, the team necessary to meet the deliverables in the desired timeframe and then assemble a team of Safety Narrative Writers to be deployed. A couple of weeks after the initial discussion, the assembled team attended a kick off meeting and began to review their first batch of cases. Each case being handled offered their own unique complexities. Some were previously written and have outdated information, others offered no previous information. It would require the team of writers to work together on common trends found in the narratives. 

For this project, we had BioPoint Engagement Managers, a Project Manager and a team of six Safety Narrative Writers work for roughly 90 days. The Engagement Managers and Project Manager worked to manage the caseload for each writer by assigning cases and QC responsibilities. Questions and updates would be then relayed back to the client periodically until completion of the project. 


Although faced with challenging timelines to reach their deliverables, the clients safety team was able to partner with BioPoint and utilize the hybrid and flexible FSP model to their advantage. BioPoint was able to quickly scale a team of experienced writers to meet their deadlines all while managing the day to day activities. The client was able to accurately estimate the time and cost to reach their deliverables and were kept up to date regarding progress.