We’ve created this FAQs page to provide clear responses to the questions that are most often asked by our clients and project partners when discussing our MyRBQM® Portal.
1. Can your RBQM platform customize TransCelerate RACT?
Yes, all available risk questionnaires in MyRBQM® Portal are customizable. However, because one size doesn’t fit all, the RACT library provides ready-to-use, indication focused RACTs; such as Oncology, Diabetes, Pulmonology, Heart Failure, Medical Devices, Healthy Volunteers-Phase 1, etc.
2. Does your RBQM platform have the ability to export data and reports?
Yes, with the MyRBQM® Portal, you can export ad-hoc reports in Excel and PDF.
3. Does your RBQM platform allow users access to how the KRIs were calculated?
Yes, MyRBQM® Portal provides a special, explanatory report on how values are being calculated for each value within the Portal.
4. Does your RBQM platform allow for KRI levels to be compared?
Yes, the KRI visualizations display the values at various levels: CRF page, site, country and protocol.
5. Can your RBQM platform predict the subject enrollment rate?
Yes, MyRBQM® Portal uses a scientifically proven algorithm to predict the subject enrollment rate (following the design of GSK and IQVIA). Both over and under-enrollment pose a risk to the cost, timeline, safety and quality objectives of a clinical trial and so the Portal’s KRI library contains two ‘gold-standard’ KRIs for under-recruitment and over-recruitment.
6. Does your RBQM platform have an audit trail?
Yes, MyRBQM® Portal is fully FDA CFR 21 part 11 compliant.
7. Does your RBQM platform provide multi-user communication and collaboration?
Yes, MyRBQM® Portal provides a user-friendly collaborative workspace to assess, mitigate and control risks. In addition, the Portal supports the use of desktop, tablet and mobile phone, so that risks can be managed anytime, anywhere.
8. Does your RBQM platform have a knowledge-library of risks?
Yes, MyRBQM® Portal has a built-in knowledge-library of over 290 categorized risk indicators that prompt users for potential risks and how to mitigate those risks. When study teams add new risks or modified existing ones, they are then added to the self-learning, growing knowledge-library. This automated feature will help study teams save time and effort when setting up the next study.
9. Can platform users drill down to subject record level?
Yes, MyRBQM® Portal’s comprehensive Patient Profiles module enables early detection of subject safety issues. For a single site and for each subject, Patient Profiles displays detailed subject data, such as medical history, visits, Adverse Events, concomitant medication, and laboratory measurements.
10. Does your RBQM platform support any type of process control?
Yes, MyRBQM® Portal’s has integrated ICH-guided workflow supported by an automated Issue Management System (ISM), ensuring that assigned tasks to the various functional representatives are being followed up and/or escalated through scheduled alerts and reminders until completion. In accordance with the ICH GCP guidelines, the Portal facilitates multi-device support and multi-user communication and collaboration to drive process efficiencies.