Trial Design to CDISC Submission
This case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through to an FDA submission for their lead product candidate. Understand the key success factors, and learn how:
- We assembled an expert multi-disclipinary team of data coding specialists, biostatisticians, statistical programmers and medical writers to support a number of the studies in the ongoing program, including pivotal Phase 2b and 3 trials
- Created of the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE).