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.
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