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.
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
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
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.