Remote Monitoring and Prequalification Audits During Restricted Travel

Remote Monitoring and Prequalification Audits During Restricted Travel

Leaders in the clinical research industry are rethinking how to conduct trials in a challenging environment. The Covid-19 pandemic has restricted travel, thus forcing companies to seek solutions to monitoring and other trial activities--such as Quality Assurance (QA) audits. ARG was positioned to respond because we already had remote monitoring and remote auditing solutions in place. Our flexibility was made possible by consistent investments in leading technologies over time, and domain experts who know how to leverage the tools and platforms.

Remote monitoring has always been incorporated into ARG’s processes, which allows us to rapidly adapt to challenging travel situations. We are able to incorporate 100% remote monitoring of clinical trial data in the Electronic Data Capture (EDC) system to perform Source Data Verification (SDV). Remote access to Electronic Medical Record (EMR)/ Electronic Health Record (EHR) data is the gold standard in remote monitoring, and we have experience working with sites that provide this option (or support conversations to allow for this option). We also recognize that electronic access of records is not feasible for every institution, so we have alternative solutions as well.

ARG has the capacity to monitor using other forms of media. Using APIs, we are able to map fields and link data points from the EMR to the EDC system. No data entry is required at the site, essentially removing the go-between. To facilitate remote monitoring of data that is not directly incorporated into the patient’s EMR, we have another solution: adding fields to the EDC to allow sites to upload a scan, PDF file or even a photograph of data reports. We recognize that telemedicine is becoming increasingly important in the healthcare industry and have updated trial-specific EDC systems to allow a site to upload a recorded telemedicine session when relevant to a particular oncology clinical trial.

ARG QA serves as a source of regulatory guidance with respect to remote monitoring, helping Sponsors understand what is important to think about when continuing clinical trials during the pandemic. In addition, QA continues to offer remote auditing of ARG via google share drive, a capability we have always used (especially in pre-qualification audits) but has enhanced value at this time. All pertinent documents are uploaded into a secure share drive, then limited (time and scope) access is set up. The ARG remote auditing process allows the Sponsor to save in both time and costs, especially when utilizing third party auditors. Remote auditing is clearly advantageous during time periods of limited travel. 

To discuss ARG’s enhanced capabilities, please contact Senior Vice-President of Business Development Mike Baker at mbaker@atlanticresearchgroup.com.