To SPA or Not to SPA: That Is the Question
In this white paper, “To SPA or Not to SPA: That is the Question. Understanding Special Protocol Assessments,” David Shoemaker, SVP of Research and Development at Rho, provides strategic recommendations for the effective use of SPAs as they relate to Phase 3 protocols. Topics include:
- Strategies for a successful SPA process
- Tips for optimal use of the SPA
- End of Phase 2 (EOP2) meetings as an alternative to the SPA
Download this free white paper, or contact us if you’d like to discuss specific considerations for your product development program with one of our regulatory experts.