DATA SCIENCE FOR CLINICAL TRIALS

Intelligent RBQM Solutions

Cyntegrity’s industry-proven expertise facilitates end-to-end risk-based quality management for your clinical trial data and patient safety.

RBQM Transformation starts here

Transform your clinical operations with Cyntegrity’s complete risk-based quality management portfolio to make your clinical studies more predictable and compliant.

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

512

Studies in the Portal

146

Sponsors, CROs, Auditors

5

Continents Covered

863

Students Enrolled

634

Academy Graduates

156

Organizations Trained

Trusted by Leading Sponsors, CROs and Auditors

Cyntegrity Customer Story: Merz Pharma

“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.”

Cyntegrity Case Studie: GenesisCare

“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.”

Cyntegrity Customer: ADAMAS Consulting

“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 report to prove it.

We have the SOC report to prove data protection

“We are extremely encouraged that our SOC 2 report has shown we have the appropriate controls in place to mitigate risks related to data privacy and security,” said Artem Andrianov, Ph.D., CEO.

“Having a data protection strategy is key. A security incident could result in an irreparable costly breach, leading to the drug or device not being approved.”

We are Honored to be Recognized by Microsoft

Read our story on the Microsoft website.

Latest Resources

Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

December 4, 2023|Comments Off on Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

Explore the impact of ICH's Q9(R1), Quality Risk Management, guideline on RBQM and clinical trials in our latest blog post. Don't miss our free infographic that simplifies this complex guideline. Enhance your risk strategies today!

Advanced RBQM Solutions: Elevating the FSP Model in Clinical Trials

November 27, 2023|Comments Off on Advanced RBQM Solutions: Elevating the FSP Model in Clinical Trials

Our MyRBQM Functional Service Provision model redefines FSP models in clinical trials with its unique, independent RBQM solutions. It offers integrated risk management strategies, AI-augmented tools like the MyRBQM Portal, and specialized training through the MyRBQM Academy, setting new industry standards.

DEKRA ISO 9001
FDA
GDPR complient
ICH GCP compliant
SOC_NonCPA