AI-Enhanced Subject Profiles

Elevating Medical Monitoring in Clinical Trials

Unified Subject Data Access

All critical patient insights in one place

AI-Powered Data Quality & Risk Detection

Proactively identify data anomalies and risks

Customizable Monitoring Flexibility

Built for unique study demands

Real-Time Patient Insights for Safer Trials

In clinical trials, efficient, precise patient monitoring is critical to maintaining patient safety and data integrity. Medical monitors oversee safety, identify potential risks, and provide insights that contribute to trial success. With Cyntegrity’s AI-Enhanced Subject Profiles (also known as Patient Profiles), medical monitors gain real-time, holistic access to essential subject data, enabling quicker, data-driven decisions and proactive risk management.

  • MedDRA integration ensures compliant, consistent adverse event tracking per GCP and ICH E6

Would you like to optimize in the area of:

  • Data Fragmentation

    • Integrating data from multiple sources, such as EHRs and lab results.

  • Delayed Signal Detection

    • Timely identification of adverse events and medication discrepancies.

  • Workload Efficiency

    • Efficiently managing data review while ensuring site and sponsor coordination.

  • Participant Data Request

    • Responding to participant data access requests quickly and easily, while maintaining compliance with ICH E6(R3) and GDPR.

Medical Monitoring Optimization Opportunities

Explore how the Subject Profiles tool can support you:

  • Real-Time, Unified Data Access

    • Quickly access subject profiles with details like Visit History, Vital Signs, Medical History, Adverse Events, Concomitant Medications, and Lab Measurements—all displayed in intuitive Gantt charts or line graphs for easy identification of outliers and trends.

  • AI-Powered Risk Detection

    • Identify anomalies across data points, such as adverse event patterns or medication inconsistencies. For instance, lab discrepancies (hematology, chemistry) against adverse events are flagged for immediate review.

  • Streamlined Workflows and Integration

    • Integrated within your RBQM system, Subject Profiles supports efficient processes, from Plan-Do-Study-Act (PDSA) workflows to Safety Review Committee meetings, enhancing data traceability and operational flow.

  • Participant Data Access Compliance

    • Create human-readable, 360° reports in one click to meet participants’ data access rights.

Key Benefits for Medical Monitors

Integrating, Syncing, and Visualizing Multi-Source Data

Integrating, Syncing, and Visualizing Multi-Source Data
Integrating, Syncing, and Visualizing Multi-Source Data
Integrating, Syncing, and Visualizing Multi-Source Data
Integrating, Syncing, and Visualizing Multi-Source Data
Integrating, Syncing, and Visualizing Multi-Source Data

Supporting Medical Monitors Throughout the Study Lifecycle

From planning to analysis, the MyRBQM® Subject Profiles tool empowers medical monitors with essential insights for informed decisions. With AI-enhanced data quality checks, study-specific adaptability, and robust security, the data source-agnostic tool aligns with regulatory standards, ensuring data integrity and seamless integration across trial demands. Customizable to each study, it includes options like Quality of Life Questionnaires and specialized lab tests, while role-based access and encryption maintain strict data security, allowing only authorized access.

Close the Loop on Patient Safety with AI-Enhanced Subject Profiles

Our AI-Enhanced Subject Profiles module, available as a standalone tool or seamlessly integrated within the MyRBQM® Portal, provides a flexible, modular solution for streamlined patient monitoring. Purpose-built for medical monitors, this adaptable system delivers real-time, comprehensive patient profiles without requiring complex enterprise implementations. Its modular design and straightforward setup make it an accessible choice for enhancing safety oversight in any clinical trial environment.

Request a Demo and Learn More

Streamline your monitoring tasks today!

Discover our RBQM Solutions

  • Technology

Perfectly suited for all trial formats, including Decentralized Clinical Trials (DCTs) and Hybrid approaches, the MyRBQM Portal puts data quality, reliability, and patient safety first.

  • People

Embrace a quality-by-design (QbD) culture with education that helps study teams grasp and reap the benefits of risk-based trial management, ensuring full adoption and compliance.

  • Process

To facilitate the successful roll-out of a cross-functional RBQM system, our Functional Service Provider (FSP) model extends to the associated processes and activities.

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This comprehensive guide (160+ pages Kindle edition) explores the principles of risk-based quality management, offering invaluable insights for optimizing clinical trials. Don’t miss your chance to be at the forefront of innovation in biopharmaceutical product development.