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Remote Monitoring in the U.S. in the time of COVID-19

Date

Monday, November 16, 2020

Time

08:00 AM America/New_York

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Agenda

The COVID-19 pandemic has put a sharp focus on the value of remote monitoring, with many trials around the world switching to a remote approach to keep critical trials moving forward during this challenging time. While this isn’t the first-time remote approaches to clinical trials have been explored, it has caused many organizations to evaluate how remote monitoring can work for their trial, what critical steps must be done in order to launch a remote-based trial, and what guidelines and requirements will apply to them, particularly in U.S.-based trials.

In this timely webinar, Alira Health’s Chris Rao, Vice President of Clinical Development and Amy Thorndike, Lead Clinical Research Associate, will join Scottish Development International to:

  • discuss the landscape of remote monitoring in the United States, discuss the history of remote approaches to rials monitoring,
  • examine considerations for U.S.-based monitoring in the COVID-19 era, and
  • provide insight on privacy concerns and considerations that sponsoring organizations should be aware of as they move forward with remote monitoring.

The presentation will be followed by a question and answer session. 

This event is a collaboration between Scottish Development International and Alira Health.

Presenter

Chris Rao

Christopher Rao, CCRP, is Vice President, Clinical Develoment at Alira Health. Chris has over 12 years of experience in clinical research, with proficiency in a wide range of indications including oncology, supportive care, medical devices, and dermatology. Chris plays a leading role in overlooking day-to-day operations in the clinical practice.

With his experience in project management, study design and monitoring, regulatory matters, and data quality management, Chris works closely with executive management and mentors of the Alira Health Clinical team.

Chris has previously served as a Project Manager at Clinical Assistance Programs (CAP). Prior to joining CAP, Chris worked as an analyst at Stone-Crowne Associates, performing pharmaceutical marketing data analysis for clients such as Johnson & Johnson as well as financial analysis for MIT and Harvard University.
Presenter

Amy Thorndike, MS, CCRA

Amy Thorndike is a Lead CRA at Alira Health and has over 15 years of clinical trial experience, with over 12 years spent as a CRA engaged in monitoring and managing clinical trials. Amy manages all day to day operations of the CRA team at Alira Health and is responsible for training, mentoring, and review of all monitoring documentation. With a strong knowledge of GCP/ICH guidelines, Amy ensures that each clinical trial is monitored correctly, within the required time frame, and that each sponsor company receives exactly the data it needs. Prior to her time at Alira Health, Amy was a Lead CRA at both Quintiles and Harvard Clinical Research Institute.