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!

Our new podcast is about non-interventional studies in the regulatory point of view. We invited Andreas Coors, an expert in regulatory affairs, to discuss the topic. He has a background in biology and neurobiology and has worked as a regulatory affairs manager for several years. Non-interventional studies are quite complicated from a regulatory point of view due to the patchwork of local applicable laws within the EU and the lack of clear regulations. The regulations for non-interventional studies are lacking for both pharmaceutical and medical device studies. Non-interventional studies are done for different purposes, some are required by competent authorities for gathering additional data, such as safety data, while others are done by the sponsor for collecting additional data. Learn more in our new podcast!

The Clinical Trial Information System (CTIS) is a centralized, web-based platform developed by the European Medicines Agency (EMA) to streamline and harmonize clinical trial submissions and regulatory processes in the European Union (EU). The implementation of CTIS is expected to have a significant impact on the Trial Master File (TMF) in clinical research. It will lead to a more comprehensive, accessible, and transparent TMF. But what problems do TMF Manager face in while working with CTIS? Learn more about it in our interview!

In this interview, Alethea Wieland discusses the transformative impact of decentralized trials on the life sciences industry. Discover the benefits of decentralized trials, including increased efficiency, patient participation, and data accuracy. Alethea addresses regulatory considerations and privacy concerns associated with decentralized trials. Gain valuable insights into the future of clinical research and the exciting possibilities offered by decentralized approaches.

Join host Dr Andreas Grund as he discusses the ins and outs of conducting clinical trials in India with industry expert, Dr Deepa Arora. They unravel the Indian regulatory environment, highlight the impact of diversity in clinical studies, and explore India's significant role as the 'pharmacy of the world.' Deepa provides valuable insights into the benefits and challenges of performing clinical trials in India, emphasizing the country's compliance with international guidelines and the quality of data produced. This enlightening discussion is a must-watch for anyone involved in pharmaceutical research considering India for their clinical trials. Don't forget to like, comment, and subscribe for more expert perspectives on the world of clinical trials.

Join us on the GCP Mindset channel for an insightful video on In Vitro Diagnostics Regulations (IVDR). Dr. Alexandra Ortiz Rodriguez, our expert guest, will cover everything you need to know. Discover the classifications in the USA and Europe, explore the differences in regulations, and learn about the significance of EUDAMED, the European database for medical devices. Gain valuable insights into the limitations of IVDR implementation, the role of notified bodies, and the importance of performance evaluation. Don't miss out on this engaging discussion!