Monitoring


Friday, September 24, 2021 at 11:00 am to 11:45 am ET                                         Track: Monitoring / Monitoring Effectiveness
Virtual Clinical Trials Using Digital Health Technologies

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


Friday, September 24, 2021 at 11:50 am to 12:35 pm ET                                         Track: Monitoring / Monitoring Effectiveness
Forging Into the Unknown:   Remote Monitoring Visits

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.


Friday, September 24, 2021 at 1:40 pm to 2:25 pm ET                              Track: Monitoring / Monitoring Effectiveness
Inspection Readiness and the Trial Master File: What You Need to Know

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