Medidata has launched Medidata Risk Management, the latest addition to its Risk-Based Quality Management (RBQM) suite, a holistic group of solutions aiming to simplify the adoption of proactive clinical operations oversight activities. These include centralized monitoring, reduced source data verification and source data review, remote source document review, and implementation of decentralized trial activities.
Built on the Medidata Clinical Cloud and fully integrated with Medidata’s centralized monitoring tool, Medidata Detect, Medidata Risk Management supports sponsors and contract research organizations (CROs) as they identify critical data and processes, associated risks, and implement mitigation strategies as defined within ICH E6 (R2). With recent updates to Medidata Detect, study teams can also compare site differences across all participants to uncover trends or anomalies and determine whether there are discrepancies in data collection or integrity to be investigated.
