Efficient Clinical Data Management

Accelerating Data Oversight in Clinical Trials

Unified Data Access

All critical information in a single, centralized view—combining EDC, lab, and external data sources

Proactive Data Quality & Risk Detection

Pinpoint discrepancies early and move forward with fewer bottlenecks

Customizable System Configurations

Adaptable to varied study requirements without extra staffing

Real-Time Coordination for Better Outcomes

Data managers often struggle with missed deadlines tied to overlooked site backlogs and delayed monitoring. By adopting continuous visibility and predictive analytics, study teams can potentially cut database lock time by weeks—without adding staff or extending work hours. This strategy keeps trials on track, controls expenses, and expedites submissions. At Cyntegrity, we’ve seen that advanced algorithms can detect site or data inconsistencies early, paving the way for swift resolution and smoother database closure.

Would you like to optimize in the area of:

  • Database Closure Delay

    • Late locks raise overall costs and risk regulatory issues.

  • Database Re-openings

    • Re-lock scenarios derail submissions and erode confidence in study quality.

  • Inconsistent Data Entry

    • Disparate site practices require extended cleaning and oversight.

  • Extended Query Resolution

    • Long back-and-forth communications add operational overhead.

  • High Effort for Edit Checks

    • Intensive coding for validation tasks slows first-subject-first-visit (FSFV).

Clinical Data Management Optimization Opportunities

Explore how the MyRBQM® Portal supports:

  • Early Risk Alerts

    • Centralized monitoring reveals potential trouble spots sooner.

  • Streamlined Query Resolution

    • Automated prioritization prevents manual backlogs.

  • Harmonized Data Entry

    • Real-time checks reinforce uniform data standards across sites.

  • Reduced Programming Needs

    • No-code statistical analysis spots anomalies without extra development work.

  • Faster Database Lock

    • Cuts time between last-patient-last-visit and readiness for submission.

Key Benefits for Data Managers

High Correction Rates? Know Before It’s Too Late!

Supporting Data Managers Through Each Phase

The MyRBQM Portal aligns with recognized guidelines (TransCelerate, FDA, EMA) and offers near real-time dashboards, encryption, and advanced analytics. Teams rely on a single source of truth for timely decisions and minimized disruptions. No additional staffing or overtime is needed—just a change in how data oversight is approached.

  • Secure and Audit-Ready – Preserves a transparent trail of changes and decisions.
  • Smooth Integration with EDC – Maintains established workflows while adding risk-based features.
  • Compliance with ICH E6(R3) & GDPR – Observes key standards for privacy and quality.

Close the Gap on Database Lock Delays with MyRBQM Portal

Delivered as a complete solution, it reduces late findings and enables confident decisions. Heads of clinical data management experience predictable timelines, improved cost control, and quality outcomes, all while meeting regulatory obligations.

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Start improving your clinical data management strategy!

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.

NEW | The Clinical Researcher’s Guide to RBQM

Discover the future of clinical research with “The Clinical Researcher’s Guide to RBQM” by Artem Andrianov, PhD, and Johann Proeve, PhD.

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.