Medidata and clinical-stage pharmaceutical company Karyopharm Therapeutics have announced an expanded partnership to bring novel machine-learning technology and targeted risk-based monitoring (RBM) techniques to clinical oncology trials.
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. Together, these unified applications have streamlined Karyopharm’s clinical trial processes: reducing electronic case report form (eCRF) design times by 74%, improving data entry time by 64%, and reducing the cycle time to open, answer and close queries by 41%.
Now, Karyopharm will realize more value from the Medidata platform by leveraging Medidata CSA and Medidata TSDV, two integral capabilities within Medidata’s Strategic Monitoring solution. CSA’s machine-learning capabilities help to identify unusual clinical trial data anomalies within a study, enabling better prioritization of resources around data quality and integrity, as well as patient safety. Medidata CSA simplifies the site monitoring process, making it easier for teams to detect and track critical data errors throughout a clinical trial, while Medidata TSDV optimizes the data verification process by enabling sponsors to configure study-specific and site-specific SDV plans.
“Karyopharm is on the front line of cancer research, pursuing novel, first-in-class drugs to accelerate hope for patients, and we’re proud to be a strategic partner in that effort,” said Mike Capone, Medidata’s chief operating officer. “Our collective teams understand the power of utilizing pioneering technologies and innovative R&D approaches to push the envelope in scientific discovery. By combining our agile, machine-learning tools with Karyopharm’s therapeutic excellence, we look forward to driving meaningful and efficient clinical research for those who need it most.”