eSource unlocks true remote monitoring benefits

Mark Joing is the Founder & CEO at Mojo Trials, a startup life sciences service provider delivering virtual site monitoring in clinical trials. He is also the Chief Operating and Financial Officer at Sanaby Health, a Special Purpose Acquisition Company created to accelerate innovation in healthcare. His 25+ year career in biopharma includes executive roles leading clinical operations and project management departments at Vyne Therapeutics (formerly Menlo Therapeutics), Nora Therapeutics, and ARCA Biopharma (formerly Nuvelo). He earned his MBA at Stanford and graduated with a B.S. in Chemical Engineering from Northwestern University. 

During the pandemic, remote site monitoring in clinical trials became a necessity.  eSource is going to be a critical tool in this trend.  In the past, the only option to monitor source data was to send a monitor to visit the site in person, a costly, time consuming, and often infrequent (e.g. every 6-8 weeks) task.  Today, tools such as eConsent and eSource allow data generated by the site to be monitored remotely in real time.  This not only saves on monitor travel time and cost, but it also sets up a real time feedback loop from the Sponsor or CRO to the site to correct errors as they occur and build quality into the data at point of entry, rather than after the data is processed through a CRF and await a monitoring visit. 

Some vendors have touted their file storage and sharing solutions as a kind of eSource solution that facilitates remote site monitoring.  While these solutions have allowed source documents to be viewed by Sponsors and CROs for monitoring in a remote location, these solutions suffer from the same problems of transcription and timeliness that reduce data quality and increase the cost of monitoring.  This is in contrast to true direct-data capture solutions in which there is no transcription or submission at a later date.  With these innovative solutions, site monitoring becomes a true SDR (Source Data Review) process rather than SDV (Source Data Verification).  This new paradigm enables continuous rather than periodic monitoring of clinical trial data, so that data quality issues can be identified and corrected immediately instead of waiting for the next monitoring visit in 6 to 8 weeks.  This in turn allows for easier identification of trends across sites in real time to give the study team actionable insights that lead to timely site retraining and acceleration of protocol improvements.

Despite the potential and promise of eSource, however, the implementation of eSource technology has not gone smoothly due to missteps in bringing a truly seamless product to the market.  I have experienced first-hand and heard from many colleagues about the frustrations with some of the existing eSource vendors and solutions.  Despite the clear benefit, this is not an easy problem to solve, and Sponsors looking to implement eSource need to carefully evaluate vendors and conduct due diligence including reference checks with other Sponsors and research sites who have successfully implemented the solution in other trials. 

I know that even better eSource solutions are on the way, and existing eSource products continue to improve.  I believe the true eSource solutions will lead to faster correction of errors and better prevention of future errors, the ability to monitor data centrally across all sites, and cost savings from reduced monitor time and travel.  And the elimination of SDV will also allow for faster database locks and time to final results.  We need more bold teams bringing innovative eSource solutions to the marketplace to provide Sponsors and CROs with a wider array of options to make eSource a reality in their clinical trials.

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