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 FDA Draft Guidance Aims to Transform Clinical Trials by Integrating RCTs into Routine Practice The FDA has […]
The FDA has just released a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry” aimed at transforming how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 This edition features details of an updated draft guidance from the FDA, Hot Topics from ADCM, details about our next RBQM webinar, and a Save the Date for your diary.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 […]
Welcome to the March edition of The Quality Issue, where we zero in on the latest in Good Clinical Practice (GCP) and RBQM news. Before we dive in, we’d like to extend a heartfelt thank you to everyone who has subscribed to our newsletter. Your engagement has been instrumental in shaping the content and direction […]
This issue starts on a note of appreciation: We celebrate Dr. Janet Woodcock’s remarkable legacy as she retires from the FDA, a journey that began in 1986. Dr. Woodcock’s pioneering introduction of risk management redefined drug safety, emphasizing a balance between benefits and risks. Her leadership has modernized drug approval and safety standards, notably through […]
