The complexities of oncology drug development have long posed significant challenges, particularly in determining the optimal dose that balances therapeutic efficacy with patient safety. The FDA’s recent guidance on dose optimization1 represents a significant milestone in addressing these concerns by refining outdated dose-finding methodologies. This article explores how dose optimization can enhance both patient safety […]
Partnership will drive quality and efficiency in clinical trials through enhanced risk-based quality management integration. [Cambridge, UK – 17.10.2024] – TRI, a leading Risk-Based Quality Management (RBQM) software provider for clinical trials, today announced it has become an official Veeva Product Partner. TRI’s OPRA RBQM platform will now be integrated with Veeva Vault EDC, providing […]
The Society for Clinical Data Management (SCDM) annual conference has always been a cornerstone for clinical data professionals, but this year’s event, held in Boston from September 30th to October 2nd, felt like a turning point for the industry. Clinical data management is on the cusp of a technological revolution, and at the heart of […]
Welcome to this month’s Quality Issue, where we spotlight some of the most important developments in clinical research and Risk-Based Quality Management (RBQM). From transformative FDA guidance to our upcoming virtual event, here’s what you need to know. FDA Draft Guidance Aims to Transform Clinical Trials by Integrating RCTs into Routine Practice The FDA has […]
The FDA has just released a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry” aimed at transforming how Randomized Controlled Trials (RCTs) for drug and biological products are conducted. If finalized, this move could reshape the clinical trial landscape by merging trials with routine healthcare […]
The U.S. Food and Drug Administration (FDA) has made a significant move to modernize clinical research with the release of its final Guidance for Conducting Clinical Trials with Decentralized Elements. Published this month, the guidance reflects the increasing adoption of decentralized clinical trials (DCTs), where activities like telehealth consultations, home-based care, and the involvement of […]
We are excited to bring you the latest updates and insights in our July newsletter. This edition features details of an updated draft guidance from the FDA, Hot Topics from ADCM, details about our next RBQM webinar, and a Save the Date for your diary. We hope you find the information valuable and look forward […]
We are excited to bring you the latest updates and insights in our June newsletter. This edition features a new white paper release, a reminder about our upcoming virtual event, and highlights from our recent travels and engagements. We hope you find the information valuable and look forward to your continued participation and support. New […]
Welcome to the May edition of our Quality Issue newsletter! This month, we’re excited to bring you a wealth of resources and events designed to elevate your expertise in clinical trial risk management. Whether you’re looking to join our complimentary virtual event, catch up on our latest webinar, or gain insights from industry leaders, we’ve […]
At TRI, we are dedicated to empowering all stakeholders in quality management by providing the most pertinent and effective tools to simplify RBQM for all clinical trials. In this issue, we are thrilled to unveil a collection of innovative tools and resources tailored to enhance your quality management processes. We have also gathered key insights […]
