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.
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.
Worldwide Pharmacovigilance Capabilities
Our client received emergency COVID-19 vaccine approval and faced the unprecedented challenge of manufacturing, distributing, and administering their vaccine worldwide, while simultaneously building out a compliant Safety Surveillance Reporting solution. This monumental undertaking needed to be done while working in lockstep with all the regulatory authorities globally to ensure successful and compliant monitoring and Safety/PV reporting.
Our client needed the internal structure to handle this profound situation and rapidly scale up its Pharmacovigilance (PV) analysis and reporting capabilities.
Pharmacovigilance Operations: Project Based FSP Support
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.
FSP Consulting Support: Ongoing Drug Safety Consulting
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…