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.
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.
627
Studies in the Portal
165
Sponsors, CROs, Auditors
5
Continents Covered
1,074
Students Enrolled
809
Academy Graduates
385
Organizations Trained
Your Clinical Data is Safe with Us!
We have the SOC and ISO reports to prove it.
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.
Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease
Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.
Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design
This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
Navigating ICH E6(R3): New Standards for Medical Monitoring
Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.
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.