From Trial Design To CDISC Submission

Background

• The sponsor is a virtually structured, specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of patients with musculoskeletal conditions.
• The company’s lead product candidate is being investigated for its potential to provide improved analgesic therapy for a highly prevalent indication.
• At the time of contracting with Cytel, the company’s lead candidate was entering Phase 2 of development.

The Challenge
Manage multiple, complex statistical analysis deliverables for a program of studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.