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 [...]
