Predictive Analytics is a very useful tool in risk-based monitoring and overall risk-based study management. It increases the proportion of correct decisions once the decisions start to become more data-driven. It also helps to understand for a central CRA or study manager the trending [...]
Today the ICH GCP Addendum E6 R2 comes into operation. Therefore, we summarized the useful resources for your kind perusal: GCP E6 R2 Addendum itself - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf PDF Mindmap of all GCP E6 R2 changes - https://cyntegrity.com/ich-gcp-addendum-e6-r2-mind-map-pdf-for-download/ ICH GCP Goes Risk Based - a [...]
Weekly RBM Feature: this is a series of articles, where we want to describe some innovative RBM features and our approach in dealing with analysis, presentation, and mitigation of risks in clinical trials. Last time we took a look at the Risk Flower chart and [...]
25.04.2016. Cyntegrity, cloud solution provider for the efficient Risk-based Monitoring (RBM), is pleased to announce its partnership with Sollers Institute (New Jersey, US). Sollers is the leader in training related to the clinical research, drug safety, and pharmacovigilance, providing the premium education according to [...]
Video from our recent CyntegrityEDU Webinar - ICH E.6(GCP) Addendum Quality Tolerance Limits Part 1. ICH E6 background (Structural & Non-structural) Quality Tolerance Limits (QTLs) Brief history of QTLs How to use the QTLs Potential benefits Part 2. Technology consideration of QTLs Considerations of enabling [...]
Four stages of RBM Evolution in a Pharma Company Intelligent software systems are facilitating the data accumulation in clinical trials already. The 75% of clinical trials are conducted with the Electronic Data Capture (EDC) [1]. The next step is to unfreeze the knowledge of [...]
How to avoid audit findings in a Risk-based Quality Management (RBQM) and risk management environment? What are auditors looking for?
The new Risk-based Monitoring concept reforms the clinical monitoring and clinical trial management. Risk factors become an important component there. What does it mean for a pharmaceutical company? Clinical trial risks are easy to foresee, site level risks and operational risks are hard to [...]
The ICH GCP Addendum E6 R(2) is final now! Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted [...]
The WHO guideline on Good Data and Record Management practices is now final, below you find the link. Particularly interesting is that this guideline talks about quality risk management: Quality risk management and sound scientific principles. Robust decision making requires appropriate quality and risk management [...]
