Medidata Risk Management

Quickly Identify Critical-to-Quality (CtQ) Factors and Drive Higher Study Quality

Many risk management approaches rely on siloed spreadsheets, and have not evolved to address the complexities of today’s clinical operations.

Medidata Risk Management provides a dynamic digital solution for risk assessment, monitoring, and mitigation. Now, you can go beyond just being compliant with ICH E6 guidelines, and instead take a proactive approach to manage study risks and ensuring patient safety.

Operationalize your risk management process in a way that spreadsheets simply can’t.

Benefits of Medidata Risk Management

Automate The Risk Management Process

Medidata Risk Management automates workflows, provides built-in risk calculations and scoring to prioritize risk levels, and enhances monitoring strategies, streamlining the user experience. The result is a system that’s fast to implement, simple to use, and flexible to adjust as your study progresses.

Build Quality Into Your Study

Medidata Risk Management creates the foundational plan for identifying critical data and processes upfront, their risks, and corresponding mitigation controls, allowing you to proactively identify issues, trends, and anomalies at every step of your trial. Inform your Source Data Verification (SDV), central monitoring and remote monitoring strategies from identified risks, so that your approach to oversight is guided by a single source of truth – the risk plan.

Integrated Platform Solution for Risk Management

Built on the Medidata Clinical Cloud®, Medidata Risk Management is unified with Medidata Detect and Rave CTMS, providing the single source of truth and deep analytic insight that you’ve come to expect from Medidata. Eliminate point solutions which don’t provide actionable insight, and move from risk to action, seamlessly.

Key Features of Medidata Risk Management

01 Supports ICH E6 and R8 Guidelines
Supports ICH Guidelines

Supports ICH Guidelines

Medidata Risk Management is fully aligned with ICH E6 (R2) and E8 (R1) guidelines and is designed to help you identify what matters most.

Record controls and mitigations on identified risks and then operationalize those mitigations into your functional plan.

02 Risk Templates Included
Risk Categorization Templates Included

Risk Categorization Templates Included

To support enhanced consistency and efficiency, Medidata Risk Management also provides you the flexibility to select from common risk categories using preconfigured templates, including decentralized clinical trial (DCT) and COVID-19 trial templates.

03 Intuitive Reporting
Intuitive Reporting

Intuitive Reporting

Intuitive data visualizations enable study teams to easily identify outliers, anomalies, and trends. Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs) can be drilled into for further granularity.

Medidata Risk Management provides actionable data and reports to support your cross-functional risk communication and to generate a Risk Plan Report after each risk assessment.

04 Integrated Data Surveillance
Integrated Data Surveillance

Integrated Data Surveillance

Medidata Risk Management is integrated with Medidata Detect, our powerful anomaly detection tool for centralized monitoring.

Detect helps you monitor for risks and take informed action when those risks are identified.

Related Solutions

Medidata Detect

Medidata Detect

Medidata Detect is a powerful data and risk surveillance tool for centralized monitoring, powered by automated statistical algorithms and machine learning.

Detect improves your study data quality and ensures patient safety throughout the trial.



Rave TSDV (Targeted SDV) enables your CRAs to focus on critical-to-quality (CtQ) factors identified within risk management activities.

It identifies Rave EDC folders, forms, and data fields that will be selectively ‘targeted’ for SDV.



Rave CTMS provides a unified solution for oversight and study management through smart workflows and embedded analytics.

Rave CTMS supports activities including study/site team creation and activation, patient enrollment and milestone tracking, site monitoring, and issue management.

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Fact Sheet

Enabling Patient Safety and Data Integrity

Medidata Risk Management supports the growing complexity of clinical trials by enabling proactive study design that includes defining and monitoring Quality Tolerance Limits (QTLs). Medidata supports you by designing quality into your clinical trials rather than a reactionary approach of monitoring quality in your trials.

Now you can develop cross-functional quality management into protocol design as well as study operations and execution.

White Paper

Modernizing Clinical Trial Oversight: The Path to Clinical Operations Excellence

The rising complexity of clinical trials, combined with pressures resulting from the COVID-19 pandemic, have forced sites, sponsors, and CROs to adopt remote and risk-based approaches (RBQM) for clinical trial execution for patient safety, compliance, and risk mitigation. 

This white paper outlines the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.


Preparing for ICH E6 (R3) Good Clinical Practice Changes

Our industry is eager to learn what changes are included in ICH E6 (R3) Good Clinical Practice recommendations this year. Understanding how taking a risk-based, fit-for-purpose approach in the use of technology to conduct clinical trials will impact the industry’s current procedures

The focus of this webcast is how sponsors, CROs and sites can focus on quality factors at the time of trial design and prepare for these new rules.

Fact Sheet

Your Path to Clinical Operations Excellence

Medidata RBQM (Risk-Based Quality Management) provides the technology and experience to transform your approach to clinical operations towards risk-based study execution models. 

Now you can continuously monitor data from anywhere, allowing you to innovate and optimize your approach to trial design, physical and virtual interactions with sites, and holistic portfolio strategy.

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