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 does [...]
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 [...]