Risk-Based Monitoring (RBM)

USDM Life Sciences and Remarque have partnered to provide an end-to end program for designing, deploying, and managing Risk-Based Monitoring (RBM) trials involving a combination of Remarque ’s product and USDM’s industry consulting services.

The Remarque System can help companies meet the ICH GCP E6 Risk Based Monitoring regulatory mandate that is expected to take effect November 2016.

USDM and Remarque, are partnering to deliver a cloud-based integrated RBM platform that will:

  • Provide comprehensive, purpose-built, risk-based monitoring software application for designing, deploying, and managing Risk-Based Monitoring (RBM) trials
  • Use advanced visualizations, analytics, and machine learning for robust risk prediction, detection, analysis and management
  • Fit into existing R&D ecosystems with no new software/hardware requirements
  • Provide the implementation, validation, and configuration services to enable a compliant RBM solution
  • Ease burden and increase the ability to scale with increasing maturity and complexity

The USDM and Remarque solution includes:

  • Comprehensive Cloud-Based Remarque RBM Software Application
  • Validation Accelerator Pack (VAP) / Qualification Package
  • USDM Implementation Services
  • USDM Project Management
  • Business Process Optimization and Engineering
  • Change Management to drive adoption of RBM

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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