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
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.
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.
Studies in the Portal
Sponsors, CROs, Auditors
Your Clinical Data is Safe with Us!
We have the SOC report to prove it.
“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.”
Subject Profiles – Review and monitor subject data with ease At the core of every study are the subjects - patients and healthy volunteers who willingly participate in a trial. As clinical researchers, [...]
Synergy of QbD, RBM, and RBQM in Trials
Clinical trials require a comprehensive approach to ensure quality and efficiency. Quality by Design, Risk-Based Monitoring, and Risk-Based Quality Management work together to achieve these goals, focusing on building quality into the trial process, targeting monitoring activities, and continuously improving trial quality.
Why the Industry Finds It Easier to Embrace Key Risk Indicators than Quality Tolerance Limits
This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.