At Signant Health, we believe progress is best done together. That’s why we launched the Imagine Forum to promote industry-wide collaboration and thoughtful discussion.  

Throughout the year, we’ll explore emerging digitalization topics and their impact on future clinical trial conduct. For our inaugural event, we examined remote monitoring and telemedicine from both the site and Sponsor perspective.  

Remote Monitoring for Clinical Trial Research 

Mitsubishi’s Dr. Amir Lahav joined us to discuss the advantages of aggregating digital data. For one, the electronic data collection produces clinical insights that were previously not possible.  

Dr. Lahav commented, “When we do [data collection] remotely, it’s more of a partnership model. We’re not milking the patients for data. We’re even giving some of the data back to the patients. The digital opportunities create a much healthier environment for clinical research.” He went on to describe how enabling remote monitoring was an important Sponsor-driven mitigation across the industry due to the COVID-19 pandemic. 

Advances In Health’s president, Melissa Poindexter, followed with her site’s experience with remote source data verification (SDV).  

“Allowing sites to be more proactive [in defining solutions for remote SDV] as opposed to reactive [during the pandemic] has been an advantage,” Melissa reflected, explaining the solution their site had put in place to enable CRAs to review source data remotely and how they were able to resource and staff this solution effectively. She also reviewed some of the other advantages she and her staff encountered.  

Advantages of Remote Monitoring for Sites  

  • Gain more control 
  • Develop SOPs 
  • Establish processes 
  • Streamline site coordinator workflow 
  • Faster turnaround 

Dannelle Palmer, Chief Operating Officer at OncoBay Clinical, explained that monitoring is not just source data verification and inspection of regulatory documentation.  For some of the elements of source data review, ensuring source data are collected according to the protocol, physical inspection of the site facilities or records is important to fill in the “gaps” and ensure there are no blind spots.  

She went on to discuss her experience with Signant’s Virtual Monitoring, saying, “We’ve actually worked with Signant to do virtual assessments because that has allowed us, even through COVID, to do full monitoring visits virtually to see what’s going on at site. You can see full remote visualization of site operations without having to travel to sites and it’s been a really flexible model.” 

Attendees also got the chance to look at remote monitoring technology through the lens of a regulatory perspective when Advarra’s Senior Director of Compliance Programs, Emily Eldh, considered their use in the context of existing regulations and guidelines for good clinical practice. In short, regulations detail what must be done, not necessarily the methodologies, perhaps opening the door to increased use of technology-enabled remote approaches.  

Increased Use of Telemedicine  

Kathleen Johnson, nurse practitioner and sub-investigator at Georgetown University, applied her learnings from a recent Alzheimer’s study to ensure effective implementation of video-based assessments in this challenging population.  She described a thoughtful approach that ensured successful patient assessments using telemedicine by using a home nurse to set up the equipment in the patient’s home, training the nurse to avoid interference with the assessment, and managing potential distractions or interruptions due to the presence of caregivers.  

Signant’s experts, Gary Sachs, Todd Everhart, and Dan DeBonis, closed out the forum by discussing practical considerations to designing studies seeking to reduce on-site visits using telemedicine and other technologies to conduct remote assessments.  The benefits of designing up-front for a site, including greater remote assessment, as opposed to implementing mitigations to existing protocols designed for on-site assessment.   

While technology provides a far more convenient participation experience for many patients, reducing on-site visits, it also brings challenges. For one, patients may feel less well cared for and less engaged with the study if there is no face-to-face contact. Telemedicine affords the opportunity to provide engaging virtual contact between the site and patient at regular intervals, ensuring patients continue to feel cared for without the need for as many physical in-clinic appointments.  

When asked about the technological considerations when selecting the right instrument, Dan commented, “There are ways to do it and it boils down to planning properly and thinking about the investment you’re going to have to make to collect some of these assessments reliably.” 

To which Gary expanded with an explanation on why Sponsors who want to use this technology need to consider assessment needs on a granular level, probing “What is it that that remote nurse is going to do? Are we going to need to reposition a camera? There are a lot of different things that might involve a caregiver in the home and having the right space and even the right lighting to make the assessment feasible.”  

Know someone who would make an excellent panelist? Contact us.  

Join the Imagine Forum LinkedIn Group for the latest updates and news. We can’t wait to see you at the next virtual event.  

Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, IRT, supply chain management, and data quality analytics.

Recent Posts

eConsent

eConsent Task Force Co-Chaired by Signant and Medidata Honored as Finalists for TOPRA Innovation Award

Learn more

eCOA

3 Reasons Oncology Studies Should Consider a Pre-Configured eCOA Solution

Learn more

eCOA

EMA Draft Guidance: Here’s What It Tells Us About BYOD

Learn more

Clinical Supplies

Direct-to-Patient Clinical Supply Distribution: Everything You Need to Know

Learn more

Scientific Advisory

AAIC Post Event Blog

Learn more