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. Does your RBQM platform allow all data to remain in the eClinical systems?
Yes, MyRBQM® Portal is designed for lean risk-based data analytics. The Portal builds an all-embracing digital neural network that spans over the entire clinical study. It allows all data to remain in the eClinical systems (EDC, CTMS, eCOA, Lab, IRT, etc.) maintaining the “single source of truth” principle. Only the specific data endpoints that are required for the key risk, performance and quality indicators are read, analyzed, and the result stored on a daily basis (and on demand), so that every data element is mastered in just one place.
There’s no need for all eClinical System data to be extracted, aggregated and warehoused, which is time consuming and costly. In addition, leaving the original data at the source eliminates the risk of errors during the data transfers from the source systems to the warehouse.
2. 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.
3. 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.
4. 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.
5. 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.
6. Does your RBQM platform support Bayesian statistics?
Yes, MyRBQM® Portal uses modern Bayesian methods as opposed to frequentist statistics. One route of clinical trial optimization is to make better use of all available information, and Bayesian statistics provides this opportunity.
Most traditional clinical trial designs are based on frequentist statistics. In frequentist statistics prior information is utilized formally only in the design of a clinical trial but not in the analysis of the data. However, Bayesian statistics provide a formal mathematical method for combining prior information with current information at the design stage, during the conduct of the trial, and at the analysis stage.
It is easier to implement adaptive trial designs using Bayesian methods than frequentist methods. The likelihood of a future event can be calculated, given the knowledge from prior events. These methods, therefore, directly address the question of how new evidence should change what we currently believe. Learn more: Bayesian Clinical Trials in Action and Predictive Analytics in RBQM.
7. 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.
8. Does your RBQM platform have an audit trail?
Yes, MyRBQM® Portal is fully FDA CFR 21 part 11 compliant. The Portal builds a complete, time-stamped audit trail of activities and system changes, providing a comprehensive view of who did what and when in the system.
9. 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.
10. 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.
11. 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.
12. 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.