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Apr 2017

Quality Tolerance Limits Video

By | April 19, 2017|Blog, Webinar|0 Comments

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 [...]

Mar 2017

On what stage of RBM evolution is your company? There are four main stages…

By | March 31, 2017|Blog|0 Comments

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 [...]

Mar 2017

4 Most Common RBM-related Audit Findings

By | March 2, 2017|Blog|0 Comments

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 [...]

Dec 2016

Video from the Webinar “Risk-based Monitoring for Clinical Research Leaders”

By | December 20, 2016|Blog|0 Comments

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 [...]

Nov 2016

The Emergence of a “Risk Monitor”: Preparing for the future.

By | November 9, 2016|Blog|0 Comments

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 [...]

Aug 2016

ICH Recommends RBM for Multi-Regional Clinical Trials

By | August 4, 2016|Blog|0 Comments

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 [...]