As summer is starting to give way to fall, the bi-annual Onsemble Conference is right around the corner. While this fall’s conference will look a little different this year, gathering virtually rather than in person, we are committed to providing the same value as if we were meeting in Madison, WI. Attendees can expect three days of collaboration and learning alongside fellow Onsemble Community members, sharing best practices on how to navigate the clinical research industry.
Over the course of three days, participants will have a variety of sessions to choose from. Below are four sessions, giving Onsemble Community members a preview of what to expect from October 6-9.
Managing Research Compliance in the “New Normal”
James Riddle, Advarra
In this session, James Riddle of Advarra will share an updated guidance from the FDA, exploring their flexibility surrounding the COVID-19 pandemic. Riddle will outline updates regarding documenting consent to utilization of telemedicine and remote endpoint verification. Additionally, he will cover topics such as remote monitoring and virtual/remote data collection, as well as best practices on documenting decisions and changes made during the pandemic.
Managing Multi-Site Studies
Brett Weaver, University of Minnesota
Join Brett Weaver as he outlines the University of Minnesota’s approach of handling multi-site study capabilities and tracking within OnCore, including setup, maintenance, and follow-up. Weaver will discuss the UMN Coordinating Center’s approach to adding and tracking separate institutions, tracking IRBs, and updating and maintaining documents. Weaver will cap off the presentation with a demonstration of the eCRF tracking for study subjects, reviewing how UMN leverages Forte EDC to establish 21 CFR Part 11 compliance for PI sign-off.
Institutional Perspectives on Stabilizing Clinical Research & Managing Communication during COVID-19
Kira Hulse & Kim Smith, Moffitt Cancer Center; Mollie Bodin & Cyndi Bower, University of Michigan School Office of Research
Throughout the COVID-19 pandemic, Kira Hulse and Kim Smith of Moffitt Cancer Center, along with Mollie Bodin and Cyndi Bower of University of Michigan School Office of Research have taken precautions in their path to continue human research studies. The Moffitt team will discuss how they leveraged OnCore to manage subjects, protocol statuses, and provide guidance for study deviations and subject status changes. The University of Michigan Office of Research will present on how they provided uninterrupted support to human research studies amidst the COVID-19 pandemic.
Rolling Out Financials and CRPC
Suzanne Calzada & Tricia Pearce, Cedars-Sinai Medical Center; Jill McKinley, Advarra
Tricia Pearce and Suzanne Calzada of Cedars-Sinai Medical Center, along with Jill McKinley of Advarra, will recount the process in which CSMC moved general research budgets and invoicing into OnCore, starting the process of centralizing financial activities. Together, they will review leadership decisions, charge master changes, process documentation, training, and adoption. They will also highlight the role of key financial processes in the overall success of the project.
Registration for our 2020 Virtual Fall Onsemble Conference is now open. To learn more about registration, and to access the full schedule, head over to the Onsemble Conference website.