Decentralized Clinical Trials
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2024 Agenda
Sat., Sept 28 1:40 to 2:25 Track: Decentralized Clinical Trials
Direct to Participant Research
Ms. Dalal will discuss the experience and process for collecting direct data from participants (no sites involved). 225
Presenter: Prachi Dalal, BPharm, MS, MBA, CCRP, Senior Clinical Program Manager, Recordati Rare Diseases US
Sat., Sept 28 2:30 to 3:15 Track: Decentralized Clinical Trials
The ABCs and GCP of Successfully Implementing Decentralized Trials
In May 2023, the FDA issued draft guidance for decentralized clinical trials. Initially embraced as a means to adapt to lockdown conditions during the pandemic, the benefits of remote clinical trial models, including greater operational flexibility, access to diverse populations of study participants, and cost savings are now widely accepted. However, as sites have more opportunities to participate in decentralized trials it is important to be cognizant of the potential GCP risks and measures sites can take to ensure participant rights, safety, and data integrity. 227
Presenter: Lisa Harewood, CCRP, Senior Clinical Trials Regulatory Specialist, Hope Clinic of Emory Vaccine Center
Sat., Sept 28 3:45 to 4:30 Track: Decentralized Clinical Trials
The New Frontier: Operationalizing Community Sites to Improve Patient Access & Diversity
Ms. Surdam will discuss the utilization and operationalization of community sites such as pharmacy chains, lab networks, and independent or local health clinics to overcome obstacles for the use of decentralized community sites to improve patient access and meet diversity requirements for clinical trials. 229
Presenter: Kristin Surdam, MS, PMP, CCRC, Senior Director, KOL & Strategy, Florence Healthcare
Sat., Sept 28 4:35 to 5:20 Track: Decentralized Clinical Trials
Clinical Research in Functional Medicine
Mr. Wehage will discuss the perspectives of a very rural community that has been involved with clinical trials for about eight years. 231
Presenter: Scott Wehage, MS, CCRP, Director, Clinical Trials