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Case studies

Drug Safety & PV


BioPoint has the broad-based experience to provide comprehensive clinical and post-marketed drug safety and pharmacovigilance consulting services to help you address product safety concerns in a confident, proactive manner.

FSP Service Provider - Case Processing, Operations, Aggregate Reporting, & Signal Detection

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.

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Compliance Remediation

Our client recently acquired and merged with a number of biopharmaceuticals within a relatively short period of time. Over the course of these acquisitions our client had partnered with a CRO to handle parts of their Case Processing Life Cycle. As time went on and more companies were acquired they were faced with 2 issues. The first was a Regulatory Compliance issue with a backlog of cases (worldwide). The second was the urgent need to scale up and properly build out their over- all Drug Safety and PV Department.

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