This package is a replay of the ACRP 2021 Virtual Program. It includes the following sessions:
The rise of COVID-19 has fast-tracked the call for innovative clinical trial solutions and about whether the traditional Sponsor-PI-Patient centric model is sustainable. Discussions of an alternative model, hybrid clinical trials, would combine elements of both centralized and decentralized systems while also leaving the door open for new technologies. But what should the patient experience in a proposed hybrid model? What could the role of advanced technology such as AI, digital patient recruitment and mobile apps be? How would decision making and stakeholder collaboration be impacted? Explore these issues and discuss best practices you can implement in 2021. Speaker: Al O. Pacino, II, President & CEO, BlueCloud by HealthCarePoint
When the world is changing by the minute in the middle of a pandemic, you hold on tight and get ready for a wild ride. Join this session to learn how to expand research operations utilizing remote technology and existing resources and how the Medical University of South Carolina used this approach to activate a COVID-19 study in our rural research naive hospitals in under one week. Hear lessons learned and how the team adapted and overcame barriers to ensure the needs of the community were met. Speakers: Amanda Cameron, MPH, CPH, CCRP, Trial Innovation Network Program Manager, Medical University of South Carolina, Signe Denmark, MS, CCRP, Associate Director Research Opportunities & Collaborations, Medical University of South Carolina, and Amy Gandy, SCTR Laboratories Manager, Medical University of South Carolina
Explore decentralized clinical trials (DCT) and the oversight role of the sponsor. During COVID-19, many trials have been modified and changed to account for the inability to interact with subjects in person and many organizations have moved to a decentralized architecture. Session participants will: understand the regulations pertaining to decentralized clinical trials, learn the perceived benefits and challenges of a DCT, and discuss remote monitoring of DCTs. Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West), FDA
Staff cuts. Furloughs. Realignments of roles and responsibilities. Pivoting to new SOPs and technologies. Remote work as the “new normal.” COVID-19 caused major disruptions in the clinical research workforce. In this panel session, leadership from sites, sponsors, and CROs will share what they learned while navigating this unprecedented workforce shake-up. They’ll share changes that were thrust upon their teams, what worked, what didn’t – and most importantly, the potential lasting impacts the pandemic is likely to have on the workforce. Speakers: Asha Collins, Head of US, Country Clinical Operations, Genentech, Jennifer Sheller, Regional Head, North America – Clinical Trial Country Operations, Merck, and Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center
Examine the coverage analysis and budgeting process, and how it interfaces with the contract negotiations in this interactive session providing tools and tips to implement right away. Speakers: Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager, Kelly Willenberg & Associates, and Deena Bernstein, MHs, SVP, Network Partnerships, Circuit Clinical
Hear straight from the experts that executed rapid study start-up and study management using a ‘no touch’ protocol while under quarantine, stay at home orders. The panel will share their real-world experience on rapid study deployment and lessons learned in developing and initiating two large randomized clinical trials studying the effects of hydroxychloroquine in outpatients with confirmed COVID-19 in under two weeks. Speakers: Jeri Burr, MS, RN-BC, CCRC, FACRP, Executive Director, Utah Trial Innovation Center, University of Utah, Dr. Nina Pacchia, PhD, CCRC, Program Director, University of Utah, and Sam Sorenson, BS, CCRC, Project Manager III, University of Utah