At Premier Research, our risk-based quality management (RBQM) strategy is powered by the Remarque platform, which brings together risk mitigation, centralized monitoring of patient data, and clinical analytics in one unified solution. Designed to meet ICH E6(R3) guidelines, our platform enables our project teams to proactively identify and address risks and issues across the study lifecycle.

With seamless clinical data integration and real-time oversight, our solution empowers teams to make faster, smarter decisions and take data-driven action quickly, while reducing the burden of traditional site management, monitoring and oversight strategies.

Core Modules Include:

• Clinical Analytics
• Risk Management
• Integration Hub

Risk Management

Our system supports our project team in delivering comprehensive oversight from First Patient In (FPI) to database lock, ensuring compliance, documentation accuracy, and quality control at every phase.

Core Capabilities:

• Complete Risk Assessment for every study
• Documenting critical data and critical process
• Assessing risks to critical data and critical process
• Documenting risk mitigation actions for every functional area
• Management of emergent issues and risks

We go beyond risk documentation—our platform links risks to mitigation plans and tracks issues through resolution, offering a defensible audit trail for regulators and sponsors alike. Dashboards provide function-specific reviews to support Central Monitor, medical monitor, and data manager review needs.

Features Include:

• Risk scoring and issues management
• Full visibility into operational risks across cross-functional project team
• Front line defenses – rule-based alerts

Integration Hub

Remarque Platform is designed to allow for flexibility in integrating across vendors and technologies. Built with interoperability in mind, Remarque’s platform seamlessly connects with over 500 systems, 100+ vendors, and processes 10 million data points daily—delivering unmatched flexibility in a fast-evolving clinical data landscape.

Data Integration Features:

• Real-time and scheduled push/pull integrations
• Flat file, ODM, SDTM, SAS, XML, and JSON compatibility
• Change-controlled incremental and full loads
• Event-based data streaming
• Data mapping utility for harmonization across systems

Clinical Analytics

We leverage technology and process to turn patient-level data into actionable insights with a unified analytics engine that consolidates all study data together in one platform. Working together in one system, medical, data management, and central monitoring teams are empowered with real-time visibility to drive faster, more informed decision-making and action.

Our platform streamlines workflows by centralizing alerts, reports, and action items within the CTMS, eliminating the need for disjointed emails, Excel trackers, or separate systems. Central Monitors can generate site-specific reports and seamlessly share them with CRAs through a single interface. This unified approach enables CRAs to quickly assess issues and determine the most effective response—whether that’s a site visit, a phone call, or another targeted intervention—enhancing coordination, efficiency, and oversight across the trial.

Analytics Highlights and Key Benefits:

• Workflow management in one system, eliminating outside documentation and disparate platform use
• Intuitive patient, site, and study-level review dashboards
• Built-in Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs)
• Study-specific dashboards for targeted safety and efficacy analysis
• View of real-time front-line defense alerts for proactive issue identification and resolution
• Sponsor-facing analytics for visibility into patient disposition and patient profiles

Why Choose Premier?

Premier Research combines deep clinical expertise with purpose-built technology to deliver smarter Risk-Based Quality Management.

• System Cohesion: Sponsor and project team will work in the same system, improving transparency and communication.
• Integrated Oversight: Central monitoring, issue tracking, and analytics in one platform.
• Purpose-Driven Platform: Designed specifically to deliver actionable insights for clinical monitoring and site management.
• Regulatory Alignment: Fully compliant with ICH E6(R3) for audit-ready oversight.
• Scalable and Flexible: Easily adapts across study phases, geographies, and vendor systems.

Discover how Premier Research’s technology-first RBQM solution can transform your trial oversight—correcting fragmented processes for unified intelligence. Contact Premier today for more details.