Challenges of Implementing CDISC SDTM Standards for FDA Submissions
Medidata's Patrick Chassaigne and PROMETRIKA's Miganush Stepanians discuss key industry trends around data management, at the recent Partnerships in Clinical Trials conference in Las Vegas. In this video, Miganush foresees upcoming challenges for pharmas around the conversion of existing legacy data to CDISC standards for submissions. With the FDA now mandating CDISC SDTM standards, data should be submitted in CDISC format in order to be truly compliant. And although some companies are struggling with legacy data from paper-based or older systems that were not CDISC compatible, many tools are now being developed to tackle those challenges.
Watch the clip for more from Patrick and Miganush.
*Guest blogger Miganush Stepanians is the President, CEO and founder of PROMETRIKA, a Medidata Services Partner.
*Guest blogger Patrick Chassaigne Miganush Stepanians serves as CRO Partnerships Director at Medidata Solutions.