The end-to-end suite will offer decentralized clinical trial (DCT) tools, as well as an eCOA oncology library, and protocol design consulting. The suite will have a single point of entry for patients, sites and sponsors.
The DCT tools include pre-built and validated applications, such as Total Consent and Televisit, Medable stated.
Total Consent is a consent management solution that is accessible on web-enabled devices, which can inform and consent participants around the world. The platform allows for compliant signatures to be collected, either digitally or wet-ink, on-site or remote with integrated Televisit.
Televisit is a compliant solution that allows for patients in clinical trials to have meetings with their doctors whilst at home. The platform can be accessed through a patient’s phone, site tablet, or through a web-enabled device. It is also able to provide push notifications, emails, and SMS reminders on the clinical trials.
According to Medable, the suite will be able to offer simplified data collection for sites and sponsors, and the notification and reminders will lead to higher compliance among patients.
The services offers real-time reporting functionality, which allows for patient- and caregiver-friendly electronic patient reported outcomes (ePROs). In this manner, clinical trial sites can also track and respond to any toxicity or tolerability signals.
The company stated that more than 22,000 cancer patients had been screened using Medable’s platform across 3,300 contracted sites and 60 countries. This led to 200% faster enrolment and a 50% reduction in costs.
“The reinvigorated Cancer Moonshot initiative coupled with the FDA (US Food and Drug Administration)’s emphasis on diversity in clinical research is driving an urgent need to improve access to cancer trials. Our DCT offering is designed around the core needs of oncology trials while enabling optionality to improve access and the patient experience,” said Musaddiq Khan, VP of Therapeutic Area Solutions at Medable.
Since the impact of the pandemic, decentralized trials have become a more significant part of the industry. This coincides with a push for greater diversity to be achieved across clinical trials, led by the FDA, but also due to the necessity to handle clinical trials remotely during periods of restricted access to face-to-face care.
During the announcement, Medable cited a study from Tufts Center for the Study of Drug Development showing that DCTs lead to net financial benefits ranging from five to 13 times for Phase II and Phase III trials.
In September 2022, Medable revealed that it had signed a four-year enterprise contract with GSK to enable DCTs across the latter company’s portfolio.
