Members of Bracken are often called on to serve as Chief Scientific Officers, Chief Financial Officers, Chief Medical Officers, or Heads of Regulatory. Some have even been pulled in to fill the position of new or interim CEO.
Our collective high-profile experience allows us to offer flexible solutions and accountability for the key decisions that help drive our clients’ business forward.
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 requirements before building out and designing the first protocol.
Bracken became the client’s in-house regulatory team, filing its first IND.
Serving as the in-house head of clinical operations and medical operations for the client, Bracken is now collaborating on clinical strategy for Phase 2.
This scenario is a common one for Bracken. Our experts are often called upon for regulatory strategy support, which then turns into a long-term partnership for the filing of INDs, NDAs, and BLAs, as well as supporting and leading meetings with the FDA.
Problem As new owners of the IP rights for a new oncology diagnostic molecular MRI contrast..
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