Navigating Your Clinical Trial During COVID-19
Sponsored by VirTrial
Tuesday, May 19, 2020 · 11:00 a.m. - 12:00 p.m. EDT
Location: Your office or conference room (no need to travel!)
The COVID-19 pandemic has had a tremendous impact on all aspects of the clinical trial process. Still, maintaining patient safety and data integrity is of utmost importance — and following shifting regulatory guidelines is key to protecting your clinical outcomes.
During this VirTrial sponsored webinar, the speakers will share how to navigate the frequently changing guidelines set by the FDA and other regulatory authorities, ways in which technology can support your clinical trials, and how to take advantage of home health and other direct to patient services during these challenging times.
Through this comprehensive conversation, you’ll find the answers you need to determine the most effective path for your clinical trials.
Kim Kundert, RN, BSN, and vice president of clinical operations at VirTrial, will share how technology can support remote trial visits and the steps sites need to take to move forward with technology-supported studies.
Robin Marcus, RN, BSN, and chief strategy officer at GlobalCare Clinical Trials, will cover the ways researchers and organizations can use home health and other direct to patient services to support patients and trials.
Melanie Flores, CIP, CCRP, and vice president of compliance at IntegReview IRB, will discuss the guidance their IRB has been providing to research sites and sponsors during the pandemic and explore what researchers should expect as their studies progress.
Key Webinar Takeaways:
- Shifting FDA and IRB Guidelines
Technology Options for Supporting Clinical Trials
- Guideline analysis to safeguard patients and study data
- Rules surrounding technology use
- Remote lab and pre-screening guidelines
Home Health and Direct to Patient Options for Supporting Clinical Trials
- Telemedicine supporting study visits
- Remote virtual interim monitoring visits
- What do I need/how do I get started
- Decentralized clinical trials- Home health support
- Pharmacy services- central pharmacy services/shipping
- Additional services: call center, data entry, and laboratories
The COVID-19 crisis has brought uncertainty to the world of clinical trials. Maintain patient safety, data integrity and trial progress with this expert guidance. Join us by registering today for this free webinar.
Who Will Benefit:
- Site operations directors and staff
- Patient recruitment, engagement, and enrollment leadership and staff
- Digital and virtual trials leadership and staff
- Innovation leadership and staff
- Project management leadership and staff
- Program development leadership and staff
- Site alliance and partner staff
- Staff responsible for patient centricity
- Site regulatory/compliance personnel
Meet Your PresenterS:
RN, BSN, and Vice President of Operations
Kim Kundert, RN, BSN, and vice president of operations at VirTrial, is an experienced research executive who previously served as the senior vice president of operations at Radiant Research/Synexus, the largest site network in the world. Kundert was responsible for overseeing operations and performance of 84 research sites across the United States. In her 19 years at Radiant, she helped develop a model of centralization and standardization for site networks and supported over 10,000 trials.
RN, BSN, and Chief Strategy Officer
GlobalCare Clinical Trials
Robin Marcus, RN, BSN, and chief strategy officer at GlobalCare Clinical Trials, has over 25 years of experience, focused on innovative executive leadership and successfully operationalizing new products and services. Her talents have been leveraged in companies of all sizes, including Caremark, Mediware, Home Healthcare Laboratory of America, and Integrity Health Care.
CIP, CCRP, and Vice President of Compliance
Melanie Flores, CIP, CCRP, and vice president of compliance at IntegReview, is responsible for the daily leadership and management of the IntegReview’s compliance program. She has worked in the Institutional Review Board industry since 1999 and has been with IntegReview since 2001.