Medidata, a Dassault Systèmes brand, and Cogstate have announced a strategic partnership aimed at transforming clinical trials for central nervous system (CNS) diseases. The collaboration seeks to improve outcomes measurement across neurodegenerative, psychiatric, motor, and rare neurodevelopmental disorders by integrating advanced technologies and expertise.
Streamlining CNS Assessments
The partnership will focus on delivering an enhanced experience through Medidata's electronic clinical outcome assessment (eCOA), which promises faster trial starts and optimized rater experiences. A key component is a streamlined rater journey via a single mobile device app, complemented by data quality assurance solutions for CNS assessments.
Unified Platform for Data Collection
By combining the Medidata Platform with Cogstate’s validated digital cognitive assessments and expert rater training, the collaboration aims to provide a fully unified platform for CNS assessment delivery and oversight. This integration is expected to increase the efficiency and accuracy of data collection.
Leveraging Mobile Technology and AI
The Medidata App, integrated with Medidata Rave EDC and eCOA features, will allow raters to manage studies more precisely, initiate patient site visits, and complete complex CNS assessments on-site. The app includes enhanced data capture features such as flexible annotation options and embedded audio recording with smart transcription to improve scoring accuracy and reduce rater burden.
Improving Data Quality and Patient Outcomes
Biopharmaceutical customers and raters will gain single-device access to ClinRO, ePRO, and PerfO assessments, including Cogstate’s digital assessments. This holistic approach aims to provide a comprehensive view of patient outcomes, with data submitted directly into Rave EDC and connected to Cogstate’s rater monitoring platform.
Expert Insights
Anthony Costello, CEO of Medidata, noted the challenges in CNS clinical trials due to the subjective nature of patient evaluation and potential for data variability. He stated that the partnership leverages Medidata’s expertise in eCOA, AI, and sensors to enable the highest endpoint data quality standard, simplify CNS trial setup, and minimize errors through automated checks on patient assessment transcripts.
Brad O’Connor, CEO of Cogstate, emphasized the importance of precise and reliable data for understanding and treating complex neurological conditions. He believes that the combination of science and technology in this partnership will deliver unique data quality innovations for more informed clinical trial decision-making and better patient outcomes.
Future Developments
Medidata and Cogstate are actively developing new ways to use CNS technology, enhance data capture, and refine patient assessment tools. Further details about the partnership and advances in CNS clinical trial optimization will be shared at Medidata NEXT New York.
