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!

In our new podcast Dr. Andreas Grund talks to expert Dr. Andreas Beust about Sponsorship as a Service. What is sponsorship as a service? For which companies is it the best option? How are competent authorities and ethics committees reacting to it?

Join us on the GCP Mindset Channel for an interview with Renata Vicente da Penha, Priscilla de Aquino Martins, and Vinícius Nunes, the co-founders of a Site Management Organization (SMO) in Brazil. Discover their journey, future plans in diverse therapeutic areas, and how they've overcome various challenges in the clinical research landscape. Learn about their efforts to educate and increase awareness about clinical trials, their utilization of technology, and their ongoing initiatives. Let us delve deeper into the untapped potential of Brazil's clinical trial market. Don't forget to like, subscribe, and stay tuned for more!