Holistic Risk-based Quality Mangement
Our RBM.Cloud builds up a “nervous system” of pharmaceutical quality management.
It guarantees early risk identification by providing a centralized location where risk data are
saved, managed, monitored, and reported.
@RACT
Risk Assessment and Categorization Tool@RACT
@RACT® – the first free cloud version of Risk Assessment and Categorization Tool, originally developed by TransCelerate Group and improved further by Cyntegrity in cooperation with PPH plus. Register today for free!
What is RBM
Risk-based MonitoringWhat is RBM
Risk-based Monitoring (RBM) is becoming an essential concept in pharmaceutical clinical research today.Which has potential to reduce clinical costs and improve data quality, and time-to-market of a medicine.
RBM.cloud
Detect, Manage, MitigateRBM.cloud
Detect, Manage, MitigateTogether with the application EarlyBird® Cyntegrity conducts total risk management of a clinical trial. It analyses data driven KRIs, builds reports and Risk-based Monitoring dashboard.
Recent Posts
RBM / RBQM Case Studies
1. Permissible Clarifications After checking the audit trail for those who entered [...]
3 Critical Aspects of Clinical Trial Conduct that Affect the Totality of Evidence
Even without it being mandated, health authorities typically expect pharma and biotech companies to conduct two well-controlled Phase 3 trials demonstrating efficacy and safety. Still today this principle ensues discussions regarding the quantity and quality of the evidence needed to establish effectiveness.
Quality Tolerance Limits versus Key Risk Indicators, The Difference
To clear up confusion surrounding the interpretation and use of QTLs and KRIs, we have created an easy to understand infographic for all clinical research experts involved in quality control.
Latest News
Your Practical Guide to Understanding Clinical KRIs
Our key risk indicator infographic will give you a foundational understanding of KRIs, provide valuable examples of KRIs, and guide you towards getting started with your risk-based monitoring (RBM) program.
2018 Has Been an Amazing Year at Cyntegrity!
2018 has been an amazing year at Cyntegrity! Thank you to everyone who made this possible!
Dr Johann Proeve awarded 2018 MCC Champion
MCC Congratulates the 2018 Class of MCC Champions: "MCC bestows this special honor to those individuals who made significant contributions in 2018 in advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials."
Cyntegrity’s RBM Platform “EarlyBird” offers a variety of useful components to support Risk Based Monitoring. I’m looking forward to the first Implementation in one of our next studies.
Cyntegrity’s @RACT is not just a cloud-based version of RACT. It is a comprehensive system that follows a solid risk management process. @RACT reinforces that process with in-depth analysis tools to support real-time decision making at both the study and enterprise levels.
Great that Cyntegrity offers a tool that operationlizes the TransCelerate RACT tool; even better that this enables through a common platform the sharing of risk assessments what will be key to quality risk management as we should learn from IATA!
I think you developed already a great tool, at least from the look and feel point of view. I have no idea how cumbersome the implementation is, how much programming is required etc. I can also imagine that coming to an agreement on what is a risk and the definition for it probably takes most of the time.
