Welcome to the GCP Mindset Channel, on this channel we inform you about the latest trends and topics in clinical research. The channel contains a mixture of presentations and interviews about several topics which are interesting for persons who work in the clinical research enviroment. The channel has been established by Dr. Andreas Grund, who works since 1997 in the clinical research world at the university and for CROs in different positions. We are happy to share our expertise for a fruitful discourse with you. Do you have a topic in mind that should be adressed in one of our podcasts? If yes, do not hesitate to contact us! The GCP Mindset Channel is powered by GCP-Service International, a 100% privately owned full-service CRO, which conducts clinical studies in several indications globally.
https://ukf9s6.podcaster.de/
Clinical Research 2.0? All you need to know about the planned ICH GCP revision
Welcome to our newest deep dive on the exciting developments in clinical research! Today's podcast is all about the upcoming ICH GCP revision – a key turning point that's reshaping the landscape of clinical trials and bringing us into the era of 'Clinical Research 2.0'. We'll unravel the crucial updates such as the shift towards fit-for-purpose systems, amplified transparency requirements, and changes to CRO outsourcing. Additionally, we'll break down the increased emphasis on risk-based quality management, showcasing its impact on your clinical trials. Learn about the latest recommendations for centralized monitoring and how new technologies and data governance procedures are transforming the roles of study sites and investigators. We'll also shed light on the proposed changes to essential clinical trial documents. This is a must-watch for everyone involved in clinical trials, whether you're a seasoned veteran or a newcomer to the field! Don't miss out on this comprehensive guide to understanding and navigating the ICH E6 (R3) revision!