With the eConsent market expected to continue its ascent over the next ten years, it’s apparent to those who have used it that the “e” in eConsent stands for much more than electronic.

Analysis and real-world examples show that it can be efficient, educational, and empathetic, leading to better participant education, reduced participant dropout, lower administrative burden for sites, reduced audit findings, and more.

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Within biosample storage, a “nightmare scenario” exists that Medable and our clients discuss regularly.

Some years ago, a sponsor with tens of thousands of biosample specimens identified that they had lost the ability to link their biobank samples' documented consent for storage (and further research). The consent for these samples was taken on paper, but a system to collate and file the consent data attributed to each specimen was not implemented. When the organization couldn’t find the paper consent, they were forced to dispose of thousands of biospecimens, losing the ability to conduct valuable research and potentially millions of dollars of lost IP.

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For the last twenty years, clinical trials have been steadily digitizing. 

As the EDC and eTMF systems of the early 2000s gave way to the eCOA and eConsent tools of the 2010s, site, and participant experiences throughout clinical research were improved. 

Since our inception in 2015, Medable has conducted over 300+ digital and decentralized trials using eCOA, eConsent, telehealth, and more. However, just as a bell curve shows, adoption rates for new technologies can wildly vary across our industry. While some organizations quickly implement new technologies, others take a more cautious approach. 

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