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Case Study

Drug Safety/PV: Compliance Remediation

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Large Boston-based BioPharmaceutical company. Rare diseases and specialized conditions.


Key Issues:

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.

This included:

      • Drug Safety case processing team clinical and post marketed cases while maintaining regulatory compliance
      • Building PV group, consisting of scientists and physicians who worked on clinical and post marketed
      • Aggregate & Periodic reports
      • Signaling
      • Label updates
      • Risk management/minimization activities
      • Ensuring regulatory compliance


BioPoint provided Drug Safety/PV consultants of varying skill sets and expertise across the company to help meet the necessary growing demand to maintain compliance.

*15 plus DSA’s reporting into Case Processing to:

      • Eliminate case backlog
      • Increase compliance metrics to a satisfactory level long term
      • Perform Triage on all cases
      • Manage and prioritize the Safety Que for prioritization
      • Act as the QC function on all cases prior to submission

Outside of helping build a Safety Team to handle their increased case volume, BioPoint also helped provide on a long term ongoing bases 10 plus MDs and 5 plus Scientists to help on a daily basis.

*5 plus Safety Scientists working on a daily basis:

      • Signaling/Trends
      • Label creation and updates
      • Aggregate/Periodic Reports
      • Risk Management activities


BioPoint’s FSP Model was shown to be effective. We continued this project as the current company was acquired within 12 months of us stepping in to assist. We worked through this new acquisition and still serve this client to date. Through this additional acquisition we re-engineered their entire case processing and still have a number of Safety Scientists and Drug Safety Physicians working for this client.