Join Us at the SCDM 2025 EMEA Conference We’re excited to announce that TRI – The RBQM Experts will be exhibiting at the SCDM 2025 EMEA Conference in Brussels, Belgium, from 9-11 April 2025. This premier event is a must-attend for clinical data management professionals looking to stay ahead in the industry. The conference will […]
Reflecting on Two Great Conferences – Let’s Talk! In this edition of the Quality Issue, we’re taking a moment to look back on two fantastic conferences we’ve recently attended. Too often, we move from one event to the next without stopping to reflect—so we’re changing that! Take five, grab a coffee (or your beverage of […]
Happy New Year, and welcome to our first Quality Issue of 2025! It this edition, we spotlight some of the most important developments in clinical research and Risk-Based Quality Management (RBQM). 2025 is going to be an interesting year for RBQM. Our prediction is that there’s going to be an increased focus on Central Monitoring […]
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FDA’s recent guidance on dose optimization1 represents a significant milestone in addressing these concerns by refining outdated dose-finding methodologies.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 FDA Draft Guidance Aims to Transform Clinical Trials by Integrating RCTs into Routine Practice The FDA has […]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 […]
