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Adjusting to Remote Monitoring During COVID-19: Working Smarter & Safer

Lessons Learned from a Virtual Town Hall held on April 3, 2020

COVID-19 ramifications on trial conduct continue to evolve at an astounding pace, requiring rapid adaptation, mitigation, and innovation. Now that the shock has worn off and we have a better picture of the pandemic’s impact on our industry, it’s time for us to get creative and find a path forward. At Halloran, we believe the most valuable way to start that journey is by working together to forge ahead. We recognize that there is no one-size-fits-all solution to addressing the impacts of our trials, but the more knowledge we can share, the faster we can get products to patients who need them most.

On April 3rd, 2020, as part of Halloran’s Virtual Town Hall series, industry colleagues convened to discuss issues and solutions specifically related to accelerating the uptake of remote monitoring (RM), conducting monitoring activities that were previously conducted on-site, (not to be confused with centralized monitoring) in the wake of COVID-19. From logistics to operations, to systems and processes, the considerations are endless when adapting monitoring to take place off-site. As we begin to chart out our next steps around business continuity, we must leverage our collective knowledge and experience. This write-up captures the key questions and answers from our 3rd Halloran Virtual Town Hall.

Getting started – general considerations

Q: I want to implement remote monitoring (RM) at my company – where do I even begin?

Q: What are the considerations for uploading documents to secure shared file areas (SFAs) (i.e. Box, SharePoint)?

Q: Should we be making changes to existing Monitoring Plans? If yes, what should we focus on?

Q: What should we consider for patients who require complex or invasive procedures that are not possible to administer remotely (i.e. transfusions, lumbar punctures, blood draws, etc.)?

Implementing RM visits

Q: Telemedicine / virtual monitoring visits are becoming more commonplace in pandemic operations – what should we consider when implementing such measures?

Q: Remote data access is a notable obstacle – how can we use the demands of remote clinical trials to set our industry’s data access standard going forward?

Enduring innovation

Q: What COVID-19 innovations could (and should) outlast this pandemic?

  1. Increased real-time data access
  2. Remote access to EMRs
  3. Telehealth/virtual solutions 

For many companies, COVID-19 is becoming the impetus for digital transformation and that’s not a bad thing. Despite the devastation, disruption, and sadness that has spread across the globe with COVID-19, we’ve seen remarkable camaraderie in our industry. These conditions have compelled us to act as one collaborative industry with one shared goal: to get life-saving therapies to patients in need. We must carry forth this mindset even after COVID-19 has run its course and reference these learnings to propel us forward. As a participant noted at the closing of our Town Hall, together we will make our trials smarter and safer!

We have offered some valuable links to additional key Guidance Document links are listed below. However, we recommend visiting these health authority websites often as they are updated frequently as new information becomes available.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Last updated March 27, 2020

EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

EMA Guidance on Points to consider on implications of Coronavirus disease COVID-19) on methodological aspects of ongoing clinical trials

MHRA’s Guidance on Managing Clinical Trials During Coronavirus (COVID-19)

UK’s NHS COVID-19: Guidance for sponsors, sites, and researchers (v2.2 26 March 2020)

U.S. Department of Health & Human Services Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency

Please also reference our previous newsletters here for more information and be on the lookout for our future virtual town halls as we continue to learn more to share.

Please reach out to us if we can help in any way or would like to be included in any of our upcoming town halls.


Laurie Halloran, CEO |
Greg Dombal, President & COO |
Paola Murphy, Chief Client Officer |
Katie McCarthy, Chief Development Officer |
Sheila Gwizdak, VP, Quality |
Kim Raymer, VP, Regulatory Affairs |
Jason Milovanovic, VP, Clinical Development |