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Case Study

Clinical Development: FSP Consulting Support – Clinical Medical Writing, Medical Monitoring, & Biostats

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A rapidly growing mid-size Biotech organization based in Southern California with a proprietary drug platform with multiple therapeutic applications.

Key Issues:

Our client had a very complex drug platform that required extensive in-house expertise in conjunction with an outsourced model to execute on a variety of different activities. The organization had a mixed experience with a CRO that was unable to provide more specialized services and resources to meet their unique business challenges.

Senior leadership was exploring different options to address unmet needs across critical projects and plan for future growth of internal functional groups while also utilizing cost-effective solution for the more routine tasks. Additionally, the Clinical Development team was further challenged with the need to utilize subject matter experts across a variety of the therapeutics areas in which the organization focused.


BioPoint assigned a dedicated Engagement Manager to tailor an FSP based growth plan that would integrate seamlessly with the client team as well as their CRO partner. Over the course of a 30 month engagement, the BioPoint team played an integral role supporting a variety of Clinical Research and Development projects such as:

    • Clinical Medical Writing – BioPoint Lead Medical Writing Executive and 2 Medical Writers worked directly with cross-functional leadership to optimize the decentralized writing process, author document templates and SOP’s, make process improvements, coordinate with CRO and external writers as well as author key documents such as Protocols, CSR, IB and NDA’s.

    • Biostatistics- The BioPoint Sr. Biostatistician and Clinical Programmer were integrated into the client team to support their Head of Biostatistics with several critical activities, including Statistical review and analysis, Charter the DMC, FDA interactions, SAS Programming, oversee CRO timelines and contribute to SAPs.

    • Medical Monitoring – 3 Medical Monitors, each with significant therapeutic experience across Oncology, Nephrology and Neurology were assigned to global client studies. In addition to providing therapeutic subject matter expertise the BioPoint Monitors were fully integrated to the client’s internal Clinical Research group and worked closely with the CRO’s Clinical Operations teams.

    • Clinical Development – Client was exploring new Therapeutic applications for several assets that utilized their drug platform. BioPoint provided a Lead Development Physician with extensive Cardiovascular experience to work with the team to explore potential new indications. The results were presented to the client executive leadership team for approval and eventual creation of a new therapeutic franchise. The BioPoint lead then helped to develop a team composed of a Medical Director and Scientist to support preparation activities such as study design, protocol development, best practices, statistical analysis plans, and to guide CRO efforts.


By utilizing a hybrid outsourcing model and FSP partnership with BioPoint, the client was able to capitalize on the subject matter expertise and strategic guidance of BioPoint resources, while still being able to outsource more routine tasks to their existing CRO partner.

The BioPoint team was able to seamlessly integrate into the client organization and alongside the partner CRO to address critical project tasks, provide strategic guidance over functional plans and allow the client to scale accordingly. In some cases, BioPoint resources transitioned to permanent employees of the client at the end of the project, while others remained ongoing resources dedicated to the client’s needs.