Quality Risk Management as A Survival Kit: From Idea to Implementation Cyntegrity is happy to present a new article at DIA global Forum written by by Randy Ramin-Wright and Artem Andrianov. The article addresses such questions as: what in embracing of RBM one should start with, [...]
The new page with the list of Key Risk Indicators (KRIs) available in Cyntegrity's RBM Cloud Solution appeared on our web-site: KRI modules. Each of the module consist from the number of specified, validated and proven KRIs. All of them are CFR 21 part 11 compliant. Each [...]
Germany is a strong player in outsourcing of clinical trials. Well known CROs as PAREXEL, PPD, ICON or PRA Health have whether subsidiaries or headquarters in Germany. There are about 140 Contract Research Organizations (CROs) in Germany and each of them has its own [...]
EPharma day Munich - RBM with EU Clinical Trials Regulation from Artem Andrianov (originally presented by Artem Andrianov on German EPharma Day) The new EU Clinical Trials Regulation (CTR) becomes applicable already on 28th of May 2016. It introduces a number of major changes in [...]
An article written by Seb Murray using his specific business-friendly and concise style about Cyntegrity and its founders: "The evolution of clinical trials, with increases in globalization, study complexity and technological capabilities, means there is a need to bring innovative approaches to drug development. Artem Andrianov, a [...]
ICH GCP Goes Risk-Based GCP Addendum Review and Embracement Plan by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD Web-View AppliedClinicalTrials, May 2015: The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes [...]
A good RBM Command Center is the heart of a clinical trial. It pumps the most important (risk-relevant) information among the team members. In order to develop a good RBM Command Center many iterations must be undertaken. Many errors have to be made. Moreover, it [...]
Click on the picture to download the full article by Moe Alsumidaie and Artem Andrianov. Many of us speak about the importance of clinical trial data quality and integrity, yet the lack of data quality standards and definitions introduces subjectivity risk in clinical [...]
© PPH plus. Dr. Schenk, hostess of the event. © PPH plus. Cyntegrity was honored to be invited to the X Interdisciplinary Drug Development Expert Workshop, which was organized by PPH plus and dedicated to burning topics of today's pharma [...]
Whether one looks for data defects in an Electronic Data Capturing (EDC) System or explores water on Mars, the methods a researcher is applying are nowadays the same. As it is very expensive to send a shuttle to our neighbor planet Mars, NASA has decided [...]