QUALITY BY DESIGN IN ACTION FOR OVER A DECADE

AI-Augmented RBQM Solutions

Enhance 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

686

Studies in the Portal

415

Organizations Trained

165

Sponsors, CROs, Auditors

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.

Proud to Earn Microsoft Healthcare AI Certification

Discover how we achieved this milestone.

Latest Resources

Cyntegrity’s MyRBQM Portal: Microsoft-Certified AI in Healthcare

January 20, 2025|Comments Off on Cyntegrity’s MyRBQM Portal: Microsoft-Certified AI in Healthcare

Cyntegrity’s MyRBQM Portal is the first clinical trial data science software to achieve Microsoft Healthcare AI Certification following a rigorous independent audit. This recognition underscores our commitment to ethical, reliable AI solutions and patient safety. Learn more about this milestone and our AI-driven advancements in clinical trials: Read the full article.

Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know

January 16, 2025|Comments Off on Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know

The ICH E6(R3) guideline was formally adopted on January 6, 2025, introducing reinforced principles for clinical trial conduct. This final version builds on its draft with clarified expectations and some notable revisions. Let’s explore the highlights and the implications for stakeholders.

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