The pharma world is expecting a new regulatory "earthquake". GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as "game changing". Clinical trial design, conducting, oversight, recording and much more is added now to GCP. Let [...]
Join the top RBM community in our newly reworked Webinar with latest RBM insights: How to improve risk awareness and mitigation from clinical study planning How RbM enhances time and financial control What the next upcoming GCP change will bring Read more and [...]
From Idea to Implementation (by Randy Ramin-Wright and Artem Andrianov) DIA Global Forum: Efficient risk management becomes more than advice today, it becomes part of a survival kit for a modern pharmaceutical company. Due to increasing trial complexity, regulatory scrutiny, competition for patients and high [...]
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 [...]
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 [...]
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 [...]
Webinar description: What risks does RbM introduce by itself? Why monitoring team does not accept the new RbM procedure? How should sites be involved in RbM process? Now, we can tackle these questions. We are going to review the definition of Risk-based Monitoring (RbM) in [...]
