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
Andy Lawton, a top expert with 35+ years of experience in clinical trials in the areas of biometrics, data management programming, system development, computer system validation and risk-based approach, joins Cyntegrity as RBM Advisory Board Member. As the global lead of Clinical Data Management at [...]
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)
Do you want to try RBM on practice? Still confused by many offers and companies? Do you want to decide yourself based on objective evidence? Apply and test our newest RBM demo environment. Explore the holistic RBM process and get a feeling how technology [...]
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 [...]
Which elements must a Risk-based Monitoring (RBM) plan must contain? What are the sponsor responsibilities regarding clinical monitoring? What kind of monitoring methods does the FDA suggest? To answer these questions, please, explore the MindMap of the "Guidance for Industry. Oversight of clinical Investigations - A [...]
[videojs width="640" height="480" mp4="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_Step_2_audio.mp4"] Source: http://www.ich.org International Council for Harmonisation (ICH) first time since 17 years is undertaking ground-shaking changes to Good Clinical Practice (GCP) guidelines. These changes take effect on November 1, 2016. In the 22 minute video above it is described how the new [...]
01.07.2016. Cyntegrity, cloud solution service provider for the efficient Risk-based Monitoring (RBM) for clinical trials, is pleased to announce a release of the newest version of its holistic RBM platform EarlyBird 4.0. The latest EarlyBird 4.0. provides new additional features which have been developed [...]
