Navigating Regulatory Challenges Associated with Decentralized Trials
Decentralized clinical trials have a complexity of guidelines in the heavily regulated clinical research industry. Additionally, new rules and variations between regulatory bodies have caused additional constraints and concern. As decentralized trials emerge and become more prevalent, so do new challenges for sites. Join us as experts in the field discuss challenges with DCTs and solutions to manage them.
Facilitator
Anthony Todd Everhart, MD, FACP, Clinical Vice President, Internal Medicine, Signant Health
Panelists
Kathleen McNaughton, J.D. CHRC, Research Compliance Officer, Mayo Clinic
Moretta Randle, Sr. Digital Health Manager, eCOA Management, Decentralized Solutions, Site and Patients, Syneos Health
Erinne Wasalski, MSHS, ACRP-CP®, ACRP-PM®, Head, Regional Site Engagement Management, Daiichi-Sankyo
Building & Maintaining a Tech-Focused Workforce
COVID-19 set an example for how digital technology can improve the clinical research experience for researchers, patients, and physicians. Now, the industry needs more people who can manage data and telemedicine platforms, home health nurses, and patients’ mobile devices. How can you enable your existing workforce to be ready for all the different technologies in trials? Learn what you need to consider when hiring new staff and how to better train them to manage technologies at the site level.
Facilitator
Kelly McKee, MS, VP, Decentralized Clinical Trials & Patient Recruitment, Medidata
Panelists
Emma Eikermann, VP, Project Manager , Mural Health
Adam Larrabee, President, Rochester Clinical Research/Atlas
Denise Windenburg, MHA, Director, Clinical Research Operations Effectiveness, Minneapolis Heart Institute Foundation
Lora Todd, Associate Vice President, Clinical Trial Foundations, Lilly
DCTs, Tele-trials, Risk-Based & Remote: How to Manage Your Contracts
While new technology has had a positive impact on clinical research, sites have felt the burden – both administratively and financially – of an accelerated and decentralized trial landscape. Implementation of technology can bring about new clauses and items within a contract that haven’t been seen before. This has led sites that may have already been in a financially precarious position to face additional expenses. Does your site understand how to identify and negotiate for new changes to tech-focused trial contracts? Join us as we learn what is needed in these contracts and how to prepare for them.
Facilitator
David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Clinical Research Compliance & Integrity, SCRS Honorary President, HCA Healthcare
Panelists
Sharon Gordon, Director of Cost Benchmarking and Site Contracts, IQVIA Technologies
Lucia Rodriguez, MS, BS, Director of Research, Evolve Clinical Research
Debra Rogge, BSN, MSA, Director, Site Management and Monitoring, AstraZeneca
Optimizing Clinical Research with Innovative Technology
Technology offers hope for the future with opportunities to improve trial efficiency. For the successful implementation of technology at the clinical research site, acceptance must happen first among healthcare professionals, patients and regulators. This session will discuss how external environmental pressures are shaping the direction in which innovation expands and how to prepare sites for evolving technologies and trends within clinical research. Understand what new technology is available and what might benefit your site’s needs.
Facilitator
Rick Greenfield, BBA-IS, Founder & President, RealTime Software Solutions, LLC
Panelists
Todd Albin, MBA, CEO, Cedar Health Research
Whitley Albright, MSN, Site and Patient Focused Innovation Project Manager, Sanofi
April Coburn, BA, MLA, Associate Director, Therapeutic Area – Site Activation Liaison, ICON, PLC
Kathy Kohler, Associate Vice President, Client Engagement, Greenphire