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Case Study: From Trial Design to CDISC Submission

This new 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. We assembled an expert multidisclipinary 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, and the subsequent creation of the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE). 

Click the button below to read the full case study and learn some of the key success factors in managing a CDISC-compliant submission.

Case Study

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 Further Reading

The Making of a CDISC Trainer

 CDISC Submissions- are you up to speed?