Virtual C-Suite

TBG 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 and then built out and designed the first protocol
• TBG 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, TBG is now collaborating on clinical strategy for Phase 2

This scenario is a common one for TBG. Our experts are often called upon for regulatory strategy support, which then turns into a long-term engagement for the filing of INDs, NDAs, and BLAs, as well as supporting and leading meetings with the FDA.