Recently, Medable worked with a leading market research consultant to identify the pains and processes that sponsors and CROs encounter when building trials. Of the many that were presented, one issue kept reappearing, the back and forth processes for building COAs. 

This feedback was instrumental in the development of Medable Studio, which was built to simplify the study build process, take eCOA off the critical path, and give sponsors and CROs total control over the trial build process. 

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Here are two statistics that may surprise you. 

Number one, according to the WIRB-Copernicus Group, the number of oncology trials has skyrocketed over the last decade, almost doubling the number of all other therapeutic areas combined. 

Number two, between 2010 and 2020, only 9 out of 108 FDA-approved oncology drugs, a mere 8.3%, included electronic patient-reported outcomes (ePROs) in their labeling.

Clearly, ePRO adoption is lagging in oncology trials. This comes despite recent guidance from the FDA (in 2021 and 2024) explaining how sponsors can use these technologies to ease trials for themselves and their patients. 

A top-10 global pharmaceutical company partnered with Medable for their pivotal Phase III diabetes study in the highly competitive market. Recognizing the inefficiencies in traditional study delivery and closeout processes, the company leveraged Medable’s expertise to accelerate timelines, enhance operational efficiency, and achieve a faster time to market for this high-profile therapy.

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