Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences, has made available its enriched solution for risk-based monitoring (RBM) of clinical trial sites. The company’s previously announced acquisition of Patient Profiles, an early stage software company focused on improving clinical trial data quality, broadens Medidata’s best-in-class technology for RBM, a methodology for reducing trial costs while providing clinical data accuracy and quality.
Founded by two former FDA statistical reviewers, Barbara Elashoff and Michael Elashoff, Patient Profiles now is available as a consulting service to Medidata customers. The Patient Profiles offering adds visualized monitoring analytics around subject and site data, providing immediate insight into clinical trial site performance and data quality. Its user-friendly software platform utilizes proprietary algorithms to predict where data errors may occur during studies, and then automatically adjusts risk indicators to allow for early detection of anomalies and outliers in clinical data—including potential fraud and misconduct.
The Patient Profiles offering will be integrated into the Medidata Clinical Cloud as part of Medidata RBM. A comprehensive, systematic approach to risk-based monitoring, Medidata RBM includes a robust combination of technology, analytics and hands-on strategic consulting services that enable life science organizations to quickly realize the quality, cost and timeline benefits of a RBM program. Through the automated review of clinical data captured in Medidata’s cloud-based electronic data capture and management system (Medidata Rave), the addition of Patient Profiles makes Medidata RBM the first cloud-based solution to provide centralized monitoring analytics using both operational data (e.g., key risk indicators, such as adverse event rates and query cycle times) and patient data.
“With its focus on centralized monitoring, Patient Profiles complements our existing risk-based monitoring offering by providing a set of tools to help monitoring teams be more targeted in their approach and identify anomalies in clinical data,” said Glen de Vries, Medidata’s president.
Along with its capabilities around site performance and data quality, the Patient Profiles offering also includes a highly configurable reporting tool that integrates data points from disparate sources and organizes them into individual patientcentric reports. The reports make it easier for clinical teams to detect critical data changes, such as those that may indicate potential adverse events.
“Risk-based monitoring is such a key area for Medidata and the industry because of its ability to improve data quality and lower monitoring costs,” de Vries added. “Integrating Patient Profiles into our platform is part of our focus on continual innovation and further enhances our easy-to-use, holistic RBM offering, which is helping sponsors and their CRO partners improve operational efficiencies and decision making throughout the clinical trial lifecycle.”