A small biotech company with their first product came to PharmaStat with Phase 2 studies in an orphan indication. The product looked promising and an NDA was planned in 18 months.
PharmaStat developed a plan for the submission, enabling the sponsor to scope it and assign resources. We then prepared the company for a CDISC implementation by providing training and practical advice. We modeled and converted eight legacy databases to SDTM and guided the sponsor to perform the analyses in-house. We created a consolidated database for the ISS, and worked with the sponsor to document the data submission according to CDISC standards.
The product was approved and the company has returned to PharmaStat for support on three more filings. With each new project, the company is less dependent on PharmaStat because the sponsor can now handle most of the job with its usual vendors.