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 [...]
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 [...]
ICH E.6 (R2) Scope of and need for Gap Analysis WEBINAR PROGRAM • ICH E.6 R2 History, Changes and Scope • Risk-based Quality Management • Quality Tolerance Limits • Risk-based Monitoring Plan • Examples • Gap Analysis • Electronic Media Validation • [...]
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 [...]
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 [...]
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 [...]
21.06.2016. Synergy, Russian fastest Contract Research Organization (CRO) and Cyntegrity, a German technology provider for efficient Risk-based Monitoring (RBM), are pleased to announce a partnership, in order to foster the practicality of RBM. Nowadays, the advantages of RBM compared to the traditional monitoring model are [...]
J. Proeve, Ph.D., an expert with 35+ years of experience as Global Data Management Head at Bayer started this week as Chief Scientific Officer at Cyntegrity. He takes the responsibility of building up a proper Risk-based Monitoring (RBM) strategy for each clinical study and develop further Cyntegrity's core product RBM [...]
