A large Biotech company began working with PharmaStat on a series of projects designed to phase in CDISC standards over time. PharmaStat conducted workshops to orient programmers and statisticians to the standards and processes used to implement CDISC models. We worked closely with the company’s capable team on a pilot project that included a legacy database conversion and culminated in a test submission of an SDTM database and define.xml to FDA.
Our work continued on a product slated for submission, with several database conversions and the production of define.xml and other documentation for a dozen SDTM databases submitted with the eCTD.
The company now has an infrastructure in place to support a data stream that produces SDTM databases and, as a result, they have far less reliance on PharmaStat.