Bracken provides a Functional Service Provider (FSP) model, embedding experienced experts directly into client teams to fill critical leadership and operational roles.
Members of Bracken are often called on to serve in functions typically held by Chief Scientific Officers, Chief Financial Officers, Chief Medical Officers, Heads of Regulatory, or Program Management leadership. In some cases, our experts have even stepped in to support executive leadership as new or interim CEOs.
Our FSP model allows clients to access high-level expertise on a flexible basis while maintaining accountability for the key decisions that help drive their business forward. Bracken professionals integrate seamlessly into client organizations, operating as an extension of the internal team.
A client scenario
Bracken was asked to help design a Phase 1 clinical trial for a novel nuclear medicine diagnostic:
Our team conducted a deep dive to understand the product and development requirements before building and designing the first protocol.
Through our FSP engagement, Bracken became the client’s embedded regulatory team, filing its first IND.
Serving as the client’s in-house clinical operations, medical operations, and program management leadership, Bracken is now collaborating on clinical strategy for Phase 2.
This scenario is a common one for Bracken. Our experts are frequently brought in to provide regulatory, clinical, operational, and program management support that evolves into long-term partnerships. These engagements often include the filing of INDs, NDAs, and BLAs, as well as supporting and leading meetings with the FDA.
The Scenario Just as strategy guides clinical development, it can guide smart, effective marketing..
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