The company that provides technology for modern clinical trials says early application of the technology in electronic clinical outcomes assessment (eCOA) deployments – a major delay to study startup industry-wide – is groundbreaking.
By automating laborious, manual tasks such as testing, Medable says it saves substantial time and removes eCOA from the critical path to trial go-live.
eCOA employs technologies such as handheld devices, tablets, or the web that allows trial participants, physicians, and caregivers to directly report information related to healthcare outcomes.
If trial participants or their caregivers are using diaries to collect medical outcomes at home, using technology makes it much more convenient to record. Not only that, it can also improve the accuracy and integrity of the endpoint data. Although much less so now, trials are still being run using paper methods to collect the data as there are some exceptions when it can be more appropriate including early phase studies with fewer participants. Although, research has found eCOA can save money and increase participant compliance.
Medable’s new AI and automation capabilities catapult the company to the forefront of automating clinical trial operations and align with the industry’s perennial need to launch studies faster. Now, sponsors can eliminate common gridlocks caused by conversion, configuration, validation, and quality engineering. Medable says the top-10 global pharmaceutical companies already benefit from its novel technology, shaving weeks off build times.
“We are reimagining the way clinical trials are deployed by eliminating many of the biggest process bottlenecks,” said Michelle Longmire, CEO and co-founder of Medable.
“Starting with eCOA, we are accelerating clinical trials while helping to improve data quality – ultimately enabling our vision of a one-day study start-up to help deliver effective treatments and cures to patients faster. In 2024, expect more innovative technologies and new ways of delivering streamlined, patient-centric trials from Medable.”
The updated eCOA capabilities include an auto-configuration tool that produces standard configurations, such as schedules of assessments, anchor dates, and patient flags, in minutes. This is part of Medable’s broader roadmap incorporating AI and intelligent automation.
The company says its auto-validate tool also eliminates weeks of tedious testing to automatically deliver a downloadable Configuration Validation Report (CVR) that validates the quality of study builds.
Medable ranked in the top 8% of software companies on the 2023 Inc. 5000, has deployed its software-as-a-service (SaaS) platform in more than 300 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants globally.
The company says its customers have achieved impressive results – including 200 percent faster enrollment and 50 percent cost reductions. A Tufts Center for the Study of Drug Development study shows that, on average, decentralized trials can achieve net financial benefits from five to 13 times for phase 2 and phase 3 trials, equating to roughly $10 million ROI and $39 million ROI respectively.
