Case Study

How WCG Statistics Collaborative Helped Breakthrough Therapy Obtain Regulatory Approval

Scaling Up CAR-T Therapies Requires Overcoming Manufacturing, Regulatory And Distribution Challenges

The WCG Statistics Collaborative team became involved in the development process early. WCG Statistics Collaborative helped design the study evaluating the therapy, prepared the final analysis and represented the sponsor in discussions with the FDA. The researchers completed a Phase 1/2 trial and needed biostatistical expertise as they moved into Phase 3. Like most small biotech companies, they didn’t have a large statistical department. Thus, they turned to WCG Statistics Collaborative. 

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