Contact Us: Main: 781.218.3790 Email: info@biopointinc.com

Case Studies


A mid-size Greater Boston based Pharmaceutical Organization with a newly approved Cancer Drug


Key Issues:
Our client engaged BioPoint after a reorganization left their Safety / Pharmacovigilance group with critical resource gaps. BioPoints’ client was looking to 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 either with their team or 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.

Solution:
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 over a twelve month period:

● 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

Conclusion:
By truly entering 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.


A large company based in Chicago that specializes in Injectable Drugs and Infusion Technology


Key Issues:
Our client was having many QA and Product Safety issues. They needed to identify their internal safety violations, implement a plan to identify and correct the compliance issues, and subsequently train Product Safety Department personnel.

Solution:
A CAPA (Corrective And Preventative Action Plan) was put into place for the Global Product Safety Department. Consultants (Project Managers, Safety Physicians, Drug and Device Safety Associates) were deployed and added to various teams within Safety in order to ensure all product safety-related issues were properly addressed, corrected and managed per regulatory guidelines.

Overall project consisted of 3 different team responsibilities:

  • CAPA Project Management consulting efforts to lead overall CAPA team in compilation, production, and oversight of health authority inspection proof books and inspection readiness. Managed Cross-functional teams between the US, UK, and Manila.
  • Safety Operations consulting utilized to manage day-to-day operations including complaints, vigilance reporting, and metrics (per regulatory standards). This team was utilized in two ways; to provide day to day operations support and to develop and administer updated training compliance seminars.
  • Drug Safety consulting utilized to develop and implement a Safety Integration Plan and team. These were successfully put into place based on a subsequent merger that was announced well into the CAPA project between two organizations (client was acquired mid-way thru project).

Conclusion:
By truly entering 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.

Back to Top