* The Agreement Introduces a New Collaboration Model to Advance the Use of Medical-Grade Sensors and Accelerate Biomarker Discovery
New York -- Medidata, a Dassault Systemes company, and Labcorp Drug Development, a global company providing clinical laboratory and end-to-end drug development services, today announced they have entered into an agreement using the Medidata Sensor Cloud. Medidata will receive and process medical-grade sensor data within drug, vaccine and device trials across Labcorp Drug Development's clinical trial portfolio, enhancing their decentralized clinical trial (DCT) offerings.
Sensor Cloud is a transformative platform for managing a broad range of sensor and digital health technology data and establishing interoperability with other clinical data sources. Launched earlier this year, Sensor Cloud integrates seamlessly with the Medidata Clinical Cloud and supports remote, continuous patient data collection from both Medidata and third-party, medical-grade sensors. This innovation provides a more comprehensive view of the patient experience through cutting-edge data ingestion, data standardization across all sensor types, and deep analytical capabilities that will ultimately lead to new digital biomarker discovery and digital endpoint deployment.
"Sensor Cloud solves key technical, operational, and analytical challenges that have historically stifled the widespread usage of medical devices in clinical research," said Ben Schlatka, vice president of digital biomarker solutions at Medidata. "This technology is urgently needed, with device usage dramatically escalating as patients, sponsors and sites demand greater flexibility during clinical trials. Combining the power of Sensor Cloud with Labcorp's innovative approach to clinical research and its scale in clinical diagnostics will transform how patient data are collected, managed, analyzed and leveraged-driving faster, more effective drug development and overall better health outcomes."
In addition, Labcorp and Medidata will use Sensor Cloud to co-develop digital biomarkers across a broad array of medical devices and therapeutic areas. The goal of this first-of-its-kind collaboration is to build a library of digital biomarkers that can be used to advance therapeutic research and create new, digital diagnostics. The first project will be an at-home version of the Six Minute Walk Test (6MWT), which is widely used in clinics to measure functional capacity in patients with heart failure, pulmonary conditions, physical function disorders and rare diseases.
"High-quality, medical-grade sensors offer the potential to understand patient disease processes with objective digital precision in a real-world setting, replacing subjective assessments that have limited clinical value," said Bill Hanlon, PhD, president of Clinical Therapeutic and Regulatory Sciences at Labcorp Drug Development. "Labcorp's collaboration with Medidata is poised to advance sensor and digital biomarker usage in clinical research in an unprecedented fashion, and will make clinical research and care processes more patient-centric, risk-based, efficient, personalized, and informative."
Digital biomarkers are often defined as objective, quantifiable physiological and behavioral data collected and measured by digital devices such as portable, wearable, implantable, or digestible sensors. The data collected are typically used to explain, influence and/or predict health-related outcomes. But, before the data can be truly useful to researchers, patients and clinicians, it must be captured, standardized and interoperable. In this way, Sensor Cloud's capabilities make it a foundational tool for sensor usage in clinical research and development.
Medidata is a wholly owned subsidiary of Dassault Systemes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.