Medidata, a brand of Dassault Systèmes and a leading provider of clinical trial solutions, has partnered with Cogstate, a leader in neuroscience solutions, to transform clinical trials and outcome measurements for central nervous system (CNS) diseases, including neurodegenerative, psychiatric, motor, and rare neurodevelopmental disorders. This collaboration aims to enhance the clinical trial experience by utilizing Medidata’s electronic clinical outcome assessment (eCOA), facilitating faster trial initiation and improving the rater experience through a unified mobile app and robust data quality assurance tools.
The partnership tackles the complexities of CNS trials by offering an integrated platform that combines Medidata’s advanced technology with Cogstate’s validated digital cognitive assessments and expert training. This will lead to higher quality data collection with improved efficiency and accuracy.
By leveraging the Medidata App, a mobile site-based solution alongside Medidata Rave EDC and specialized eCOA features, raters will be able to manage their studies with greater precision. The app simplifies patient site visits and intricate CNS assessments, providing enhanced data capture capabilities, flexible annotation options, and audio recording with smart transcription to improve scoring accuracy while reducing the burden on raters.
Biopharmaceutical companies and raters will have access to all ClinRO, ePRO, and PerfO assessments through a single device, including Cogstate’s validated digital assessments, enabling a comprehensive view of patient outcomes. Data from CNS assessments will be submitted directly into Rave EDC, seamlessly integrating with Cogstate’s monitoring platform for quick review and query management, leading to faster trial starts, superior data quality, and a simplified rater experience.
“The subjective nature of evaluating patients and the potential for data variability create significant challenges in CNS trials,” stated Anthony Costello, CEO of Medidata. “By leveraging our expertise in eCOA, AI, and sensors, we aim to uphold the highest standards of data quality, streamline trial setups, and automate checks on assessment transcripts to reduce the study team’s workload and minimize errors.”
Medidata’s CNS Suite integrates advanced sensor technology and AI-driven analytics to address unique trial challenges, utilizing the Medidata Sensor Cloud and myMedidata to collect and analyze a wide range of biometric and behavioral data. This approach provides deeper insights into patient outcomes while ensuring a patient-centric trial experience through a unified portal.
“The ability to deliver precise and reliable data is vital for understanding and treating complex neurological conditions,” said Brad O’Connor, CEO of Cogstate. “Our partnership merges scientific expertise with innovative technology to enhance data quality, informing clinical trial decisions and improving patient outcomes.”
Both Medidata and Cogstate are committed to advancing CNS technology and enhancing data capture and patient assessment tools. Leaders from both companies will present insights about their partnership and the latest advances in optimizing CNS clinical trials at Medidata NEXT New York.
