By Clinical Informatics News Staff 

November 9, 2017 | Medidata has launched its Strategic Monitoring suite, a new offering within the Medidata Clinical Cloud, to enable clinical research teams to collaborate and manage all cross-functional, risk management, and centralized data monitoring activities. The tools meet ICH E6 guidelines.

In conjunction with Life Science Strategy Group, Medidata recently conducted a double-blinded survey of 70 end users and decision-makers of RBM technology and asked them to rate the major vendors. Medidata’s original RBM offering was already one of two vendors with top ratings for both Product and Professional Services implementation. Now, by integrating Medidata Strategic Monitoring into a seamless cloud platform with advanced analytics, the company hopes to lead and transform monitoring throughout clinical research.

"We created Medidata Strategic Monitoring after carefully reviewing the regulatory position papers, ICH Guidelines and TransCelerate RBM technology requirements," said Kyle Given, managing director, strategic monitoring at Medidata in a statement. "This system was designed to create a unified analytics platform for centralized monitoring, enabling Sponsors and CROs to identify patient, site and study level risks, and implement a set of traceable corrective actions that helps sites comply with protocol requirements; ensuring patient safety."

Medidata Strategic Monitoring uses machine learning for adaptive monitoring, ensuring enriched data quality through early, real-time, unique insights. The new solution integrates directly with Medidata Rave and the Medidata platform, able to be deployed on studies directly on the Medidata Clinical Cloud.

Glen de Vries, president, Medidata, added in the same statement: “Medidata’s cloud platform facilitates a comprehensive approach to risk-based monitoring, in an intuitive interface, and with full compliance to regulatory guidelines and industry best practices. Medidata is the only platform today that provides a complete solution to clinical operations for sponsors and CROs; fully integrated with scientific data management workflows focused on patient outcomes.”