MyRBQM® Portal:
Quality by Design in Action
Quality by Design in Action
Clinical studies are increasingly integrating a quality-by-design (QbD) methodology, requiring in-depth risk-based quality management (RBQM) software to optimize workflows and data management.
With integrated ICH-compliant workflows, the MyRBQM Portal facilitates a quality-by-design clinical trial risk management approach.
One platform. Complete end-to-end Risk-Based Quality Management.
How can we help?
As life scientists, we understand that each clinical trial is different and has its own unique challenges and risk profiles.
That’s why we’ve designed flexible, end-to-end risk management solutions that cater to your needs, including integrated collaboration tools to facilitate teamwork across functions.
Whether you are a CRO, a sponsor, or a regulatory body, our services are for you.
Meet the MyRBQM Portal
The MyRBQM Portal is an AI-augmented cloud solution that facilitates GCP-compliant, end-to-end risk-based quality management.
Risk Assessment
Risk Management
Issue Management
Key Risk Indicators
Centralized Statistical Monitoring
Subject Profiles
Predictive Analytics
Site Monitoring
Get ahead with integrated risk identification, categorization and assessment.
Ready-to-use therapeutic area-specific and custom RACT templates facilitate AI-augmented risk assessment and categorization, ensuring consistency across all your trials.
Control risk impact detectability and probability through in-depth insight and action assignment.
Assign mitigations, prepare for known risks and ensure that your patients' safety and data quality are always looked after according to protocol requirements.
Receive real-time notifications of any issues, risk events or threshold breaches, and respond immediately.
The Portal's intuitive issue management system allows rapid response to issues, cross-function communication and follow-up and integrated RCA and CAPA capabilities.
Know the status of your risks with a best-in-class, built-in Key Risk Indicator engine and unique knowledge risk library.
Ensure that all risks are adequately monitored with the Portal's vast library of KRIs with the capability of creating custom KRIs according to your needs.
The Portal's integrated Centralized Statistical Monitoring tool, allows quick to access, easy to use statistical analysis on chosen data sets.
Monitor trends and patterns in clinical and operational data to identify anomalies and potential risks.
Easily monitor patient data using Subject Profiles and identify any anomalies before they become risk events.
This integrated, customizable module allows a complete and up-to-date overview of all incoming subject data, from visit history and vital signs, adverse events and complex quality-of-life questionnaires.
Equipped with powerful Machine Learning models, the Portal shows superior predictive analytics precision for clinical data.
Integrated predictive analytics, that continuously adjusts based on previous study performance, allows monitors to get ahead of risk events, trends or patterns that may occur.
Site monitoring is made easy in the Portal's intuitive Sites module, facilitating a quick and easy overview of a site's performance.
Complete site risk performance information is available on demand, thus limiting the need for frequent site visits, and reducing the time to respond to any issues.
“Ask AI” for enhanced guidance
Advanced predictive analytics
All risks and activities in scope
ICH E6 (GCP) & E8 (QbD) compliant
Ensuring you don’t overlook any blind spots.
Stay ahead of the curve with ML-driven risk predictions.
From EDC to CTMS, integrate with all e-clinical data sources.
Ensuring each study is quality-driven and approval-ready.
Join instructor-led or on-demand RBQM Essentials courses and become an expert in your own time, drawing from years of deep clinical research expertise.
Complimentary to our best-in-class software solutions, our functional service provision model will facilitate successful RBQM transformation.
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.
