Edge Strategic Monitoring

Paving the way to the new risk-based approach with a comprehensive platform to ensure logical and statistical data quality across all of your monitoring functions

Risk-based monitoring and ICH E6 (R2) GCP Compliance

Are you launching a risk-based monitoring (RBM) study? You don’t need to blaze the trail.

With Edge Strategic Monitoring (formerly Strategic Monitoring), confidently comply with ICH E6 (R2) GCP requirements, provide full transparency to regulatory authorities and maintain inspection-ready status while planning and implementing your risk management and centralized statistical monitoring methodologies. 

Holistic, Quality-Based Approach to Monitoring

At Medidata, we view monitoring as the end-to-end management of data quality, ranging from initial protocol development to database lock. We created the Edge Strategic Monitoring suite by working closely with TransCelerate members to ensure we optimally adhere to ICH E6 (R2) GCP Guidelines. The suite is designed to meet the RBM Functional Requirements as defined in the TransCelerate Risk-Based Monitoring Technology Considerations (Part 2 - Dec 2015). It is the only fully traceable, closed-loop, risk management planning and collaboration platform for the next generation of clinical trials and includes: 

Risk Assessment: Assess impact, probability, detectability of study risks. Configure and link Key Risk Indicators (KRIs)/Analytics.

Centralized Analytics: Review known and unknown risks through the use of statistical, machine-learning analytics. Generate issues/actions.

Visit Preparation: CRA reviews issues/actions created by centralized risk monitoring team. Prepares adaptive monitoring plan focused on risks.

Visit Conduct: CRA completes assigned tasks including Source Data Review (SDR), root cause analysis and preventative/corrective actions

Documentation: CRA captures visit conduct responses, associated comments, issues and action items in visit report

Features and Benefits

Achieve Smart, Collaborative and Streamlined ICH E6 (R2) Compliance with Edge Strategic Monitoring

  • SMART - Enriched data quality through early, real-time and unique insights
    • Statistically analyze millions of data points to identify known and unknown risks, anomalies, outliers and patterns
    • Assess impact of actions on data quality through configurable workflows and KRI performance tracking
    • Simplify data verification process through configurable study and site-specific Source Data Verification (SDV)/Source Data Review (SDR) plans
  • COLLABORATIVE - Strengthened cross-functional study team collaboration
    • Allow different functional teams to review critical risks centrally
    • Manage all cross-functional risk management activities through seamless end-to-end workflows
    • Track workflows centrally through easy to read flags, highlights or alerts
  • STREAMLINED - Seamless data flow across a holistic unified platform
    • Enable CRAs to efficiently prepare for upcoming visits through simplified SDV/SDR plans with advanced tracking
    • Provide greater workflow efficiency and reduce administrative burden on CRAs
    • Streamline site visits and increase visit reporting productivity by automating routine functions

TESARO Talks About Edge Strategic Monitoring Consulting Services

After months of struggling to launch their risk-based monitoring program, TESARO turned to Medidata. And less than three months later their first Risk Based Monitoring study is underway. Listen to TESARO, an oncology-focused biopharmaceutical company, tell their story.

talk to a representative

We can customize product solutions to your unique clinical trial needs. Connect with us to learn more about Medidata and discover how we can help you accelerate your clinical trial process.

Additional Resources


Risk-Based Monitoring: The Missing Link Bringing Drugs to Market Efficiently

White Paper

TransCelerate RBM Technology Considerations Document


Day In The Life Of A CRA

White Paper

eBook - The Ultimate Starter Kit For Risk Based Monitoring

White Paper

Practical Considerations of A Successful RBM Implementation