Risk Management in Clinical Trials | Medidata

Medidata Risk Management in Clinical Trials

Identify and manage the risks most important for your trial's success

At Medidata, Risk Management equals quality. Risk Management is the foundational step to support risk-based quality management (RBQM). It’s more than meeting ICH, FDA and EMA recommendations for Good Clinical Practices, it’s about proactive Quality by Design (QbD) and ensuring patient safety. Medidata Risk Management provides a standard, repeatable process to identify risks, develop mitigation strategies in the event of an issue, and support patient safety and higher data integrity during the clinical trial process.

Your first step in the risk-based quality management journey

Identify critical data and processes (Critical to Quality factors) and controls before a clinical trial for greater patient safety and data quality.

Why Medidata Risk Management?

Enable Proactive Risk Management

Medidata Risk Management creates the foundation for identifying risks and corresponding mitigation controls to proactively identify issues, trends, and anomalies at every step of the clinical trial. Risk Management focuses monitoring on trial processes most likely to affect patient safety and data quality so that sponsors, CROs, and investigators can quickly and effectively mitigate risks or address errors before they affect trial quality.

Automate the Risk Management Process

Many study teams currently use a spreadsheet to list potential risks, which is often siloed, outdated, and unable to provide adequate reports for cross-functional communication. Medidata Risk Management automates the process and provides built-in risk calculations and scoring to prioritize risk levels and enhance monitoring strategies, simplifying the process for users.

Access Intelligent Reports

With Medidata Risk Management, study teams can easily identify outliers, anomalies, and trends by viewing data visualizations, that include Quality Tolerance Levels (QTLs) and Key Risk Indicators (KRIs), and can be drilled into for more granular details. The solution provides actionable data and reports to support cross-functional risk communication as well as generate a Risk Plan Report after each risk assessment.

Leverage Platform Capabilities

Built on the Medidata Clinical CloudTM platform, Risk Management leverages the unified platform to create a single source of truth for all study-related data. It creates your Master Data Management across clinical studies and allows you to access an end-to-end suite of Rave applications for Data Capture, Data Management, Trial Planning, Trial Management, and Analytics.