CELEBRATING 10 YEARS OF ADVANCING CLINICAL TRIALS

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

EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science

September 19, 2024|Comments Off on EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science

The EMA has released key guidelines on the responsible use of large language models (LLMs) in regulatory science. Discover how AI tools like GPT can streamline tasks while addressing privacy and accuracy challenges, and learn about the EMA’s approach to safe and ethical implementation.

Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

September 11, 2024|Comments Off on Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).

The Real Cost of Delays in Drug Development and the Role of RBQM and QbD

August 8, 2024|Comments Off on The Real Cost of Delays in Drug Development and the Role of RBQM and QbD

Recent Tufts CSDD research shows that the cost of clinical trial delays is much lower than previously thought, underscoring the importance of Risk-Based Quality Management (RBQM) and Quality by Design (QbD). Cyntegrity's Johann Proeve, PhD, and Anastasia Shapovalova, MSc, highlight the benefits of a data-driven approach and live process monitoring in enhancing trial efficiency.

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