Remarque Systems Secures Industry’s First Patent For Trial-Audited, Real-Time, Risk-Based Quality Management Platform

Capturing Every Action Taken Entirely Within Its RBQM SystemProvides Permanent Audit Trail, Enabling Rapid Compliance

MORRISVILLE, N.C., September 28, 2021 — As regulatory oversight increasingly focuses on risk-based monitoring (RBM) technology, clinical trial sponsors need a straightforward way to input and audit data in real time. Remarque Systems’ platform is the industry’s first patented trail-audited real-time risk-based quality management (RBQM) system.

Remarque Systems recently secured a patent for its RBQM system; the system makes it easy for sponsors to monitor for risks and comply with audits — and do so in real time.

“Our patented process enables a sponsor to instantly go back years to track their every action, each of which is time-stamped,” said Remarque Systems’ President and Co-Founder Mike Arlotto. “The platform enables any source data system to plug into Remarque Systems, which gives sponsors an all-inclusive pathway for identifying and managing risk.”

How It Works:

  • Audit trail. A comprehensive and permanent audit trail of all study actions and data allows users to reliably trace activities, which is particularly useful for expediting fast compliance with any regulatory audits or 483 queries.
  • Risk alerts. A checklist capability enables sponsors to set up alerts about risks to patients, data quality, and/or integrity of the trial — all of which become part of the built-in audit trail and are instantly accessible.
  • Real-time monitoring. Unlike other platforms, Remarque Systems allows for 24/7 tracking of risks, study progress, and other data.
  • Risk-based quality management. The system filters all study data within the platform. As a result, teams can collaborate on risk management and compliance measures, ending error-prone processes and giving sponsors the visibility to react swiftly and effectively.
  • Comprehensive clinical trial management system. The system connects all site documentation and study data within the centralized platform.
  • Real-time data analytics. Sponsors are armed with clear, data-driven, and actionable insights.

Learn more about Remarque Systems and how its technology can help you find the most effective way to manage your clinical trial:

About Remarque Systems 
Remarque Systems provides a single, easy-to-use, and effective platform to manage all of your clinical trial data. Remarque Systems brings all your data from different sources together in real time; delivers end-to-end visibility and oversight with data-driven analysis, monitoring, and risk assessment; and drives better-informed decisions with clear and conclusive analytics, reports, and visualizations. By consolidating your data on one powerful platform, Remarque Systems brings process optimization, increased visibility, rapid communications, and improved quality to your clinical trials. 

Contact: Michael Arlotto, Remarque Systems President and Co-Founder,