Contributed Commentary by Fred Martin

May 16, 2018 | The introduction of new technology often generates apprehension for those looking to bring increased efficiency, cost reduction, and quality improvements to their organizations. This is especially true in a highly regulated industry like clinical research. When something new comes along, most tend to take a cautious approach, observing early adopters from afar before deciding whether to make their own investments. These next-wave adopters have a perceived benefit of proven products without the anxiety of being “the first.” In clinical research, eSource has now crossed this chasm from early adoption to mainstream criticality. Organizations that have invested in eSource have eliminated the costs and inconveniences associated with paper, shortened trial timelines, and enhanced monitoring. These benefits, combined with parallels to electronic data capture (EDC) adoption history and FDA support of electronic technology, make it clear that eSource is on the cusp of becoming the next indispensable technology in clinical data management—one that stands to bring significant competitive advantage to those who recognize this and move quickly to adopt.

This places the industry at a crossroads: Which organizations will recognize this moment for what it is – and why does it matter?

Recognizing a historical parallel

Despite the clear benefits of eSource, paper source documents are still in use – at least for now. In investigating the reasons for this, it’s important to note that skepticism about eSource today recalls the skepticism with which the industry regarded EDC years ago. The skeptics worried about the cost and time needed to implement EDC, how much it would change established internal processes, and unclear regulatory support. But as the software became more reliable, inexpensive, and easy to use, the perceived barriers disappeared, and EDC technology became an industry standard. To not have an EDC solution today is to be at a clear competitive disadvantage compared to the vast majority of sponsors and CROs that have made EDC an integral part of their workflow.

The evolution of eSource is following the same script. When eSource first appeared, site managers were wary of abandoning paper source documents in favor of a brand new technology. But in the years since, eSource has proven worthy of becoming the new standard, and many tested systems beat paper in measures like security and reliability. Organizations that adopted early are already receiving the benefits of paperless trials, especially with eSource integrated with EDC. It seems the reasons for not adopting it have more to do with resistance to change and perhaps a lingering suspicion of technology. Organizations that have moved past those concerns, however, are reaping the benefits of finishing the job that EDC started—the elimination of paper from clinical data capture.  These organizations will become the centers of choice for conducting clinical trials, leaving late adopters unable to compete.

Receiving FDA support

eSource and its benefits are so well established at this point that the FDA, in its “Guidance for Industry, Electronic Source Data in Clinical Investigations,” promotes its use. The document says: “In an effort to streamline and modernize clinical investigations, this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.”

Adding the stamp of approval from the FDA to an already demonstrably-beneficial technology is another indication that eSource is poised to become a new standard in clinical trial technology. 

Enhancing your competitive position

Adopting EDC has already made paper an endangered species at many organizations. As it became a reliable and preferred method of data management, users got a range of benefits, including cleaner data, minimized queries, quicker study completion, and increased data security. Now it’s eSource’s turn—and those who have recognized that will lead the way for the rest of the industry.  

The time is now to join the ranks of those leaders. For sites that want to streamline their data collection procedures, ensure a regulatory-compliant audit trail, and improve their competitive position, eSource is an indispensable enabling technology. Adopting it now is the smart, strategic approach to positioning your organization for the future of clinical research.