Karyopharm and Medidata Expand Clinical Trial Partnership

In addition to renewing its use of the Medidata Clinical Cloud platform--including key capabilities within Medidata's study conduct and site support suites--Karyopharm is adopting Medidata CSA (Centralized Statistical Analytics) and Medidata TSDV (Targeted Source Document Verification) to enhance its data review process and incorporate modern risk assessment practices into its drug development programs. "As we advance our most promising cancer therapies, it is vital that Karyopharm embraces the latest technologies and evolving trends in the clinical trials space. Adopting Medidata's machine-learning capabilities for centralized monitoring will not only put us in line with the updated ICH E6 R2 guidelines, but will also allow us to view clinical information at a more holistic level, better prioritize trial resources, and maintain data quality and integrity," said Ran Frenkel, chief development operations officer at Karyopharm. "Medidata is more than our technology provider of choice--they are a valued partner that is helping us reach our scientific goals sooner ." A Medidata customer since 2014, Karyopharm has been using Medidata's industry-leading electronic data capture (EDC) and management system, Medidata Rave, as well as integrated capabilities that plug into Rave--including randomization and trial supply management, medical coding, adverse event reporting and clinical trial management--to advance its pipeline of oncology-focused therapies.