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Build Quality and Risk Management Into Your Clinical Operations

Apr 14, 2021 - 2 min read
Build Quality and Risk Management Into Your Clinical Operations

Today’s agile clinical trial operations are grounded on the principles of Risk-based Quality Management (RBQM) using a data-centric strategy with actionable insights to enhance decision making capabilities. A successful RBQM strategy requires integration and harmonization across multiple data sources and complex workflows. Medidata is unifying RBQM and clinical trial management, delivering the ability to define and execute a holistic, end-to-end risk-based quality management and monitoring strategy from initial protocol development to database lock.

Risk assessment is the first step in developing a proactive approach to support quality by design (QbD) principals. This process begins before your trial starts and continues throughout trial activities. Study teams identify critical to quality (CtQ) factors, build a strategy to support what’s important, evaluate performance objectively, and adjust strategy as needed. The solution identifies, manages and mitigates risk while ensuring patient safety, and ensures data quality, clinical responsibility, reliability of trial results, and compliance. Throughout the life cycle of the study, risks are monitored according to quality tolerance limits (QTLs) and key risk indicators (KRIs), and controls and remediations are implemented when needed.

In keeping with this approach, Medidata recently launched Medidata Risk Management. This solution is a foundational step to a Risk-based Quality Management (RBQM) strategy, which supports the overall success of clinical trials. Medidata Risk Management was built to support ICH E6 (R2) recommendations for quality management and streamline the complexity of compliance while keeping the focus on patient safety.


Risk management fundamentally equals quality—an ideal risk management solution provides a standard, repeatable process to identify and mitigate risks, ensure patient safety, and improve data integrity.

Streamline Your Risk Management Process
Old-fashioned risk management methods used spreadsheets and manual data entry. These processes siloed data and consequently complicated risk management, leaving mitigation controls hidden in spreadsheet cells without automatic reporting or communication capabilities. 

Rather than rely on manual processes, technology built on a unified platform connects workflows and builds communication into the process. Medidata Risk Management evaluates risk across CTQ Factors (critical data and processes),  identifies risk controls (Risk-based Monitoring activities) so teams can proactively respond to issues that may arise, and easily identify anomalies and trends through intuitive visualizations and graphics. As part of the Medidata Clinical CloudTM, Risk Management connects to other applications to continuously inform you with near real-time data.

Proactively Address Issues
Risk Management works with Medidata Detect to provide real-time data to monitor risk indicators and effectiveness of mitigation strategies. In addition, Medidata Detect identifies unknown risks so new issues can be tracked to support continuous improvement efforts and study teams contribute to the risk management process.

Additional key features and benefits of Medidata Risk Management include:

Modular & Scalable: While implementing an RBQM strategy in support of global recommendations can seem daunting, Medidata provides a modular approach that meets your needs today while providing the capability to scale as additional functionality is required.

  • Actionable Data: Medidata Risk Management centralizes information, calculates risk scores, and monitors results based on KRIs and QTLs, allowing for more effective management of risk while ensuring patient safety and data integrity.
  • Greater Efficiencies: Many companies invest in technologies that operate in silos, which is very inefficient. Given that there are redundancies across processes, data and clinical study teams, our solution helps break down those silos, creating more efficient operations, collaboration and data sharing, which supports better business decisions and  proactive patient safety.

Learn more about how to identify and manage the risks most important for your trial's success with Medidata Risk Management.

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