What’s new in MyRBQM Portal V6.0.8?
We’re constantly working to improve your MyRBQM Portal experience, here’s a summary of what has changed:
IQRMP Export Feature
The enhanced Excel RACT export now provides study teams with an easy to download Integrated Quality and Risk Management Plan (IQRMP) style template. Here’s what TransCelerate says about IQRMP:
The IQRMP provides a tailored and integrated plan for a specific clinical trial that will Include the clinical and medical risks identified at the program level, define the actions that each function will take to proactively identify, assess, and manage risk throughout the life of a clinical trial, define the critical data variables identified by cross-functional representatives (e.g. elements and/or processes that impact primary efficacy endpoint and critical safety parameters), align associated quality management plans (including the monitoring plan) across identified risks and defined critical data variables, so that cross-functional teams can focus on the risks that are most important to patient safety, data integrity and regulatory compliance. [TransCelerate]
Easy Export & Import of Study Risk Assessments
This new version release also allows you to export and import any of your study risk assessments. We’ve made it easy to duplicate study risk assessments if you have twin studies or similar protocols.
Indication Focused Heart Failure RACT
We’ve added a new indication focused RACT to our MyRBQM® RACT library. Heart Failure RACT helps you generate risk management plans faster and easier and be well-positioned for study audits. Our constantly growing MyRBQM® RACT library currently holds 6 indication focused RACT catalogs, which are built on the universal TransCelerate spreadsheet methodology: Heart Failure, Oncology, Pulmonology, Diabetes, Cardiovascular and Medical Devices.
Read also: Challenges Associated with Clinical Research in Heart Failure by Dr Johann Proeve, CSO Cyntegrity
More CSM Algorithms…
We have implemented more, proprietary Centralized Statistical Monitoring algorithms, which we will demonstrate during our free webinar on “Fraud and Sloppiness Detection in Clinical Trials (Part II)” scheduled for January the 21st. Why don’t you join us? Register here.
Good de-risking of your clinical trials!
– the Cyntegrity team