Ms. Baloga will cover all aspects that go into conducting clinical trials in a virtual setting. The benefits of implementing virtual aspects into a trial and/or transitioning pre-existing trials into a virtual design will be discussed. 517
Presenter: Elizabeth Baloga, MPH, CCRP, Senior Project Manager, University of Rochester
Ms. Guilbault will discuss centralized monitoring practices and how the COVID-19 Pandemic impacted sponsors’ ability to conduct on-site monitoring visits thus transitioning visits to remote monitoring visits. Strategies for obtaining and reviewing electronic medical records remotely will also be discussed. This session is geared toward monitors with a minimum of 6 months of centralized monitoring experience. 519
Presenter: Kimberly Guilbault, MSN, RN, CCRP, Senior Regional CRA, BIOTRONIK, Inc.
Inspection Readiness - two words that can ignite fear, stress, and worry. Ms. Ehdaivand will share how the Trial Master File should be utilized to support inspections and result in no findings. 521
Presenter: Sholeh Ehdaivand, BA, President and CEO, LMK Clinical Research Consulting LLC