A small to mid-sized biotechnology company with an mRNA-based pipeline in the greater Boston area.
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.
Biopoint, a distinguished pharmaceutical consulting solutions provider, was engaged to assemble and deploy multidisciplinary teams of seasoned PV/Drug Safety consultants that included MDs, Scientists, Epidemiologists, Project Managers, PV Operations Specialists, and PV Systems Support.
Due to BioPoint’s industry expertise and extensive network, specialized teams were quickly onboarded across our client’s PV/Drug Safety team to support highly critical functions and activities: Medical review, safety surveillance, signal detection using advanced data analytics and methodologies, author aggregate reports including MSSR’s, provide strategic input, communicate with global regulatory authorities, perform literature review, provide follow up on CAPAS, deviations, inspection observations as well as create tracking systems.
Through swift deployment and strategic expertise, BioPoint was pivotal in enabling our partner’s successful global vaccine launch. This collaboration ensured worldwide regulatory compliant Pharmacovigilance analysis and reporting capabilities that allowed for growth to handle a tremendous and ever increasing case volume. BioPoint remains a trusted partner, providing reliable multi-disciplinary and cross-functional support as required.