Article | January 12, 2021

Why Remote Site Monitoring Is On The Rise And How To Deploy It At Your Organization

By D’Anna Siegle, Senior Product Marketing Manager, Florence

Telehealth Remote Clinical Trial

The COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring. Remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, clinical research organization (CRO), and the research site.

The sponsor or CRO must ensure that the research site conducts the trial per the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and any other regulatory requirements.

To oversee these activities, sponsors/CROs historically have monitored sites by sending information through email, fax, or online portals; and holding on-site monitoring visits. Ultimately, when conducting an IND trial, regulations require the sponsor/CRO to guarantee the:

  • Rights and safety of patients are protected
  • Reported trial data is accurate, complete, and verifiable from source documents
  • Conduct of the trial is compliant with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements

Although the FDA suggested shifting to remote monitoring in 2013, the industry has been slow to adopt remote monitoring technology until the COVID-19 pandemic made traditional monitoring impossible. To explore FDA guidance for remote site access and COVID-19, please visit this resource.

In this article we explore:

  • Challenges of Traditional Monitoring
  • Benefits of Remote Clinical Trial Monitoring
  • How to Deploy Remote Clinical Trial Monitoring
  • Sponsor-Deployed Remote Monitoring Technology
  • Site-Procured Remote Monitoring Technology

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