Risk-Based Monitoring Maximize the benefits of your Risk-Based Monitoring strategy by utilizing out-of-the-box functionality for SDV, Data Review and eSignature. DATATRAK ONE EDC and CTMS can generate KRIs, KPIs, and sponsor defined metrics for every step of clinical trial workflow, customizable to align with your processes and resource needs. This functionality allows the creation, implementation, and monitoring of both static and dynamic plans in real-time. These metrics are supported with dashboards that provide study health, recruitment, monitoring, data cleanliness status and reports.   WEBINAR: Risk-Based Monitoring Adoption Simplified This webinar provides a framework to assist in developing a Risk-Based Monitoring plan. Presented by DATATRAK and Algorics. View Ensure ICH E6 (R2) Compliance  DATATRAK partners with Algorics to ensure our clients are able to take clinical and operational data directly from the DATATRAK platform, and ensure customers are meeting the standards laid out by the ICH guidelines.  The DATATRAK ONE platform, used in conjunction with Algorics Acuity, eliminates many of the pains of data integration and standardization, allowing for faster and more robust RBM data visualization and analytics. It is critical that data is easily available from across multiple sources including, but not limited to EDC data, with CTMS and Randomization data providing strong markers of risk.  The Algorics’ Acuity analytics platform pulls data directly from DATATRAK and in a validated environment allows customer teams to work together to capture risks, and develop mitigation strategies and KRIs in a transparent way, before monitoring those risks against clinical and operational data in real time as the trial is performed. Features of RBM with DATATRAK: Percentage of overall data calculated automatically based on data quality monitoring, critical data and safety data. User quality scores based on data points entered, data points SDV’d, and queries that caused data change.  Remote data cleaning supports secure and centralized management of study documentation. Our powerful ad-hoc reporting module let you configure your reports to the specifics of your RBM plan to identify early data trends and quality issues. Edit checks activate upon data entry, reducing time, cost, and the amount of queries across the trial. Operations insights provide real-time data aggregation of trial data across systems and across protocols. Risk Based Management provides and end-to-end solution for Risk Based Monitoring, aligned with the most recent ICH E6 (R2) guidelines. Portfolio oversight gives transparent reporting of progress across a portfolio of trials without vendor or CRO dependency. Remote Monitoring allows surveillance of clinical trial progress with focus on risks, delays and inspection readiness. Have a Question About Risk-Based Monitoring? A DATATRAK expert is ready to help you find the answer. Send us a message, and our experts will contact you shortly.  Message

Risk-Based Monitoring

Maximize the benefits of your Risk-Based Monitoring strategy by utilizing out-of-the-box functionality for SDV, Data Review and eSignature. DATATRAK ONE EDC and CTMS can generate KRIs, KPIs, and sponsor defined metrics for every step of clinical trial workflow, customizable to align with your processes and resource needs. This functionality allows the creation, implementation, and monitoring of both static and dynamic plans in real-time. These metrics are supported with dashboards that provide study health, recruitment, monitoring, data cleanliness status and reports.  

WEBINAR: Risk-Based Monitoring Adoption Simplified

This webinar provides a framework to assist in developing a Risk-Based Monitoring plan.

Presented by DATATRAK and Algorics.

Ensure ICH E6 (R2) Compliance 

DATATRAK partners with Algorics to ensure our clients are able to take clinical and operational data directly from the DATATRAK platform, and ensure customers are meeting the standards laid out by the ICH guidelines.  The DATATRAK ONE platform, used in conjunction with Algorics Acuity, eliminates many of the pains of data integration and standardization, allowing for faster and more robust RBM data visualization and analytics. It is critical that data is easily available from across multiple sources including, but not limited to EDC data, with CTMS and Randomization data providing strong markers of risk.  The Algorics’ Acuity analytics platform pulls data directly from DATATRAK and in a validated environment allows customer teams to work together to capture risks, and develop mitigation strategies and KRIs in a transparent way, before monitoring those risks against clinical and operational data in real time as the trial is performed.

Features of RBM with DATATRAK:
  • Percentage of overall data calculated automatically based on data quality monitoring, critical data and safety data.
  • User quality scores based on data points entered, data points SDV’d, and queries that caused data change. 
  • Remote data cleaning supports secure and centralized management of study documentation.
  • Our powerful ad-hoc reporting module let you configure your reports to the specifics of your RBM plan to identify early data trends and quality issues.
  • Edit checks activate upon data entry, reducing time, cost, and the amount of queries across the trial.
  • Operations insights provide real-time data aggregation of trial data across systems and across protocols.
  • Risk Based Management provides and end-to-end solution for Risk Based Monitoring, aligned with the most recent ICH E6 (R2) guidelines.
  • Portfolio oversight gives transparent reporting of progress across a portfolio of trials without vendor or CRO dependency.
  • Remote Monitoring allows surveillance of clinical trial progress with focus on risks, delays and inspection readiness.
RBM whitepaper download

Have a Question About Risk-Based Monitoring?

A DATATRAK expert is ready to help you find the answer. Send us a message, and our experts will contact you shortly.