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Case Study

Drug Safety/PV: FSP Service Provider – Case Processing, Operations, Aggregate Reporting, & Signal Detection

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A mid-size Greater Boston based pharmaceutical organization with newly approved cancer treatments and a robust oncology pipeline.

Key Issues:

Our client engaged BioPoint after a reorganization left their Safety / Pharmacovigilance group with critical resource gaps. BioPoint’s client was looking to more slowly scale up their in-house Safety division, relying on outside partners to support the necessary clinical / post marketed product safety functions, and provide operational PV assistance.

Senior Safety leadership at the client required a flexible yet highly specialized partner to act as a Functional Service Provider. It was essential that this partner be able to meet evolving project deliverables, quickly assemble the necessary resources and integrate them with their team or act as stand-alone experts. It was also important to our client that they be able to maintain central oversight with real time access to BioPoint consultants.


BioPoint assigned a dedicated Engagement Manager to tailor an FSP offering that addressed our client’s need for an accelerated yet flexible service delivery configuration. BioPoint’s Safety/PV SME’s became familiar with our client’s products and processes allowing for a more streamlined assembly and deployment of resources as projects dictated.

BioPoint coordinated a comprehensive team of 6 Safety Physicians, 3 Safety Scientists, 5 Drug Safety Associates, 2 Pharmacovigilance Operations Specialists, and a PV Auditor. Working both onsite and remotely, the BioPoint team was able to effectively meet deliverables in the following areas

        • Case Processing – Full Data Entry, Coding, Narrative Writing, Query Generation, QC, CRO Liaison
        • Case Assessment – Medical Review, Causality Assessment, ICSR Signal Screening, Periodic and Adhoc safety reports
        • PV Operations – SDEA Creation, PV Audit and CAPA plans, SOP / WP review


By truly integrating into an FSP alliance with its client, BioPoint was able to provide increased control, full transparency of project deliverables and timelines, as well as substantial operational and cost efficiencies. Our client was in a position to address critical business needs while having the ability to more strategically transition to direct internal staff. BioPoint’s consultants remained available to assist with training as new employees were assimilated into the Safety/PV group.