QUALITY BY DESIGN IN ACTION FOR OVER A DECADE

AI-Augmented RBQM Solutions

Cyntegrity’s suite of integrated solutions enhances operational efficiency with end-to-end risk-based quality management.

Cost-reduction in ClinOps begins here

Optimize your clinical operations with Cyntegrity’s AI-augmented risk-based quality management portfolio. Reduce costs while enhancing predictability and compliance in your clinical studies.

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.

  • Study insights on the go
    through fast, high-volume data analytics

  • Get ahead of risk events
    with ML-driven predictive analytics

  • Efficient user interface​
    through an automated GCP workflow​

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.

  • Relevant and current courses
    that follow the latest guidelines

  • Interactive and engaging
    ensuring you get the most out of each class

  • Supported by industry-experts
    from clinical and regulatory backgrounds

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.

  • Study protocol evaluation
    for risk assessment and mitigation

  • Design of RBQM SOPs
    based on GAP analysis

  • Centralized Monitoring​
    combined with statistical expertise​

99.99%

Availability SLA

627

Studies in the Portal

165

Sponsors, CROs, Auditors

5

Continents Covered

1,074

Students Enrolled

809

Academy Graduates

385

Organizations Trained

Trusted by Leading Sponsors, CROs and Auditors

“By using Cyntegrity’s unique RBQM technology we were able to retrospectively analyze a real world clinical study and conduct a workshop to successfully generate new ideas for further improvements on a global scale.”

“We would recommend other CROs to consider Cyntegrity Germany GmbH for their clinical risk-based quality management needs. We have had a satisfactory experience with them for the expert services they have rendered to us.”

“Working with Cyntegrity was a fine example of a collaborative process. They have a strong understanding of regulatory and industry requirements. The team was open to discussion and was a pleasure to work with.”

Your Clinical Data is Safe with Us!

We have the SOC and ISO reports to prove it.

We have the SOC report to prove data protection

Dr. Dipannita Mitra, Head of Quality and Process Management, shared, “It’s an exciting moment for us as we started this year with two major wins: we earned the ISO/IEC 27001:2022 and SOC2 Type 2 certifications. These certify that we’re doing our best to keep up with strict global standards.”

“It’s a clear sign of our dedication to making sure we’re keeping your data safe and secure,” she added.

We are Honored to be Recognized by Microsoft

Read our story on the Microsoft website.

Latest Resources

Why EDC Needs RBQM for Smarter Clinical Trial Management

January 14, 2025|Comments Off on Why EDC Needs RBQM for Smarter Clinical Trial Management

With ICH E6(R3) reinforcing proactive quality management, relying on EDC systems with hundreds of edit checks is impractical. The MyRBQM Portal bridges the gap with predictive analytics, historical data views, and real-time risk drill-downs, enhancing oversight and reducing complexity. Learn how EDC and RBQM work together for smarter, compliant trial management.

Maximizing Site Readiness for ICH E6(R3)

January 9, 2025|Comments Off on Maximizing Site Readiness for ICH E6(R3)

The ICH E6(R3) guideline redefines expectations for clinical trial sites, emphasizing proactive planning, data accuracy, and risk monitoring to enhance participant safety and trial efficiency. Download our presentation for practical insights and strategies to ensure compliance and strengthen collaboration.

Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy

December 31, 2024|Comments Off on Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy

The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management. Combined with RBQM principles, sponsors can streamline trials, enhance safety, and align with regulations.

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.

DEKRA ISO 9001
FDA
GDPR complient
ICH GCP compliant
SOC_NonCPA