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 [...]
Picture source: http://independentaudit.com/tweeting-audit-findings-colour/ How to avoid audit findings in Risk-based Monitoring (RBM) and risk management environment? What are the most common findings in RBM? What are auditors looking for in risk management plans, SOPs and RBM guidance? If we can imagine a pharma hell, this [...]
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 article covers the topics of clinical trial budgeting when applying the risk-based monitoring (RBM) model. The problem is that the new monitoring model requires a new model of clinical trial budgeting too, while today, the common practice is to apply traditional fixed-price budgeting. [...]
Pharmaceutical companies and contract research organizations (CROs) are increasingly trying to leverage technology to optimize risk-based monitoring. While technology is a critical component, roles also need to be looked at again. Recently we interviewed Dr. Nimita Limaye, an expert in risk-based monitoring, about the future [...]
Click here for downloading the PDF version. Based on the source: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf
As RBM is its infancy, it is vital to understand how to measure its success, so that we all would have a chance to reflect and correct our path if needed. An interest of adding an RBM technology to clinical trials emerges in pharmaceutical companies [...]
The Webinar conducted by Andy Lawton (Global Head of Data Management at Boehringer Ingelheim) and Ellen Kelso (Executive Director at Chesapeake IRB)
On 6th May 2016, a draft guideline of the International Council on Harmonisation (ICH) “General Principles for Planning and Design of Multi-Regional Clinical Trials” was published, the aim being to make global multinational clinical trials safer and more trustworthy[1]. ICH advises applying a unified quality standard across all [...]
