Navigating the FDA's Draft Guidance on DCTs—A Roadmap for Trial Sponsors

In May of 2023, the FDA released a new Draft Guidance on decentralized clinical trials (DCTs). This important Draft Guidance offers recommendations for trial sponsors as they navigate the incorporation of virtual trial elements, ushering in a new era of innovation. In this webinar, Science 37 and a group of clinical trial sponsors will discuss how to implement decentralized clinical trials that align with regulatory guidelines

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/decentralized-clinical-trials

Event Overview:

In May of 2023, the FDA released a new Draft Guidance on decentralized clinical trials (DCTs). This important Draft Guidance offers recommendations for trial sponsors as they navigate the incorporation of virtual trial elements, ushering in a new era of innovation. The FDA recognizes that DCTs offer significant benefits and recommends the use of virtual conduct to help increase diversity and inclusiveness in trial populations, stating that "remote clinical trial visits and clinical trial-related activities are important strategies to make trials more convenient and more accessible to trial participants."
Join Science 37 and a group of clinical trial sponsors for a conversation on how to implement decentralized clinical trials that align with regulatory guidelines.

Key Learning Objectives:

• Deliver study execution and oversight to meet regulatory guidelines
• Expand patient recruitment beyond traditional research sites
• Leverage local HCPs for trial-related procedures

Who Should Attend:

• Pharma, BioPharma and CROs

Speakers:

Jonathan Cotliar
Chief Medical Officer
Science 37

Jonathan Cotliar, MD, has been Chief Medical Officer of Science 37 since November 2016. Prior to assuming this role (from November 2016 to May 2019) Jonathan served as Vice President of Medical Affairs for Science 37, where he contributed as an investigator on a number of virtual clinical trials in addition to his work in support of business development and regulatory strategy. Dr Cotliar currently serves as Director of Inpatient Dermatology at Harbor-UCLA Medical Center, with previous full-time faculty appointments at the David Geffen School of Medicine at UCLA, Northwestern University Feinberg School of Medicine, and City of Hope National Medical Center. He was Chief of the Division of Dermatology at City of Hope, previously. Dr Cotliar earned his BA from Trinity College, MD from the University of Kentucky College of Medicine, and completed his training in dermatology and internal medicine at the David Geffen School of Medicine at UCLA. While at UCLA, he completed a NIH-sponsored K30 Fellowship in translational investigation. Dr Cotliar is also board-certified in both internal medicine and dermatology.

Irena Lambridis
VP, Global Head of Quality Assurance & Compliance
Science 37

Irena Lambridis has spent nearly 20 years working in quality-focused leadership roles, primarily for small and mid-sized CROs building teams and leading global trial quality oversight. Throughout her career, she has focused on creatin g an environment of logical and meaningful quality processes that support organizations in gold standard execution of the trials they support. Now leading Science 37's quality function as VP, Head of Quality Assurance & Compliance, Irena continues to bring her QA toolbox and years of quality experience to Science 37 as they build the future of clinical trials within a decentralized space, ultimately serving the people who need life changing and lifesaving therapies the most.

Amy Bohn
Director, DCT Operations
Bayer

Amy Bohn, Director, DCT Operations at Bayer works with clinical and operational teams to implement Decentralized Clinical Trials. Amy’s journey to DCT Operations began in 2005, when she joined a start-up organization pioneering remote central ratings to address the high failure rate of clinical trials in CNS indications. Over the course of a decade, she held leadership roles scaling the operations from small start-up to global CRO provider. Her experience with remote ratings, telemedicine, eCOA, and digital platforms is a natural transition to the modern day decentralized clinical trial.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/decentralized-clinical-trials