Signal Driven Risk Based Monitoring for Clinical Research

Risk-Based Monitoring (RBM)

Signal-Driven RBM integrated directly into eClinicalOS

 

 THE TOP LINE
  • Identify and address potential risks before they become problems
  • Improve quality, safety and compliance while decreasing costs up to 25%1
  • Ready your studies for anticipated regulatory changes (ICH E6 GCP guidance)

With the expected adoption of new ICH E6 Good Clinical Practice (GCP) guidelines just around the corner, it's no surprise that researchers are searching for a reliable and practical Risk-Based Monitoring (RBM) solution to make their trials safer, faster and more cost-efficient. 

As the industry's leading EDC provider, Merge eClinical has teamed up with Remarque Systems to deliver the most advanced signal-driven RBM solution available. This unique integration of a purpose-built RBM application into a comprehensive EDC platform allows end-to-end study management in an audit-trailed RBM environment. A cloud-based, SaaS model, Remarque RBM fits right into your existing system, and no additional software or hardware is needed.

The Remarque RBM platform gives you real-time data exchange and robust risk assessment tools along with role-based views and functions. Plus, the integration with eCOS EDC means you can go beyond merely identifying risk: Now, you're prompted to take immediate action. You can modify, add or update key risk indicators, triggers and thresholds at any point to reflect changing trial conditions. And with all trial data at your fingertips, the time from study end to results is shorter than ever.

Key Features

The integrated eCOS and Remarque RBM solution offers:PSD-RBM_SCREEN_GRAB_1_FOR_WEBSITE.png

  • A knowledge engine that uses machine learning and statistical algorithms to predict, detect, analyze and manage risk
  • Built-in RACT or Risk Register to assess and document risks
  • Protocol-specific site scoring that helps you evaluate site performance
  • Customized alerts that notify you immediately of potential concerns
  • Robust workflow functionality built into every role
  • Interactive role-driven visualizations with drill-down capabilities
  • System-agnostic data intake to import data from any source in any format
  • A Medical Monitor Module that allows the medical monitor to quickly identify and address safety concerns and anomalous data trends 
  • Workflow packaging capabilities that let you efficiently manage optimal mode (email, phone, and visit) and cadence of site contact 

eCOS is the only EDC platform that offers this much power, exibility and functionality to conduct RBM trials. And just like eCOS, Remarque RBM is scalable, so it grows as you grow.

Motti, Eduardo F., M.D. “Risk-Based Monitoring: Have Investigators Been Served?” Pharmaceutical Outsourcing. March 26, 2015


 

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