Medable launches new decentralized trial software to speed vaccine development - MedCity News

Medable is perhaps the strongest company in the field of decentralized clinical trials. If fundraising is a measure of success, the company has raised more than $521 million since its founding in 2012 — significantly more than its competitors, which include Curebase, Science 37 and Clara Hello.

On Tuesday, Medable made its product offerings more robust with rolling out new software solution. The software is designed to speed up decentralized vaccine trials so pharmaceutical companies can better respond to disease outbreaks such as monkeypox, Covid-19 and flu variants. It’s not the first company to release software designed for decentralized vaccine trials — Curebase is, in fact released a platform for home-based Covid-19 vaccine trials in 2020

Medable’s “core” vaccine trial product includes a preconfigured set of modules that handle things like participant prescreening, electronic consent, televised visits, electronic clinical outcome assessments, and real-time data reporting. Pharmaceutical companies and clinical research organizations can deploy the basic solution in as little as five weeks, Musaddiq Khan, Medable’s vice president and head of therapeutic area solutions, said in an interview.

The “Flex” version of the vaccine trial product includes all the same tools as the core solution, along with customized digital tools designed to meet the specific needs of the trial protocol. Examples of these customized tools include automated data access through sensors and wearables, more sophisticated clinical outcome assessments, and integrations with additional electronic data capture systems and interactive technology response systems. The flexibility proposition also allows pharmaceutical companies to conduct trials in more than 60 languages.

This “off-the-shelf solution” eliminates much of the technical burden for pharmaceutical companies to build and could reduce trial launch times from more than 12 weeks on average to five weeks, Hahn said.

“It’s important to remember that this is an effective solution that reduces the time to deploy technology that supports the operational delivery of vaccine trials – the scientific questions that need to be asked will still need to be answered,” he added.

The rate of innovation in vaccine research was quite low before the pandemic, according to Hahn. Now that scientific innovation is beginning to take off in the vaccine field (think mRNA technology used in Pfizer and Moderna’s Covid-19 vaccines), it’s time for operational delivery to modernize as well, he argues.

The pandemic has shown how quickly pharmaceutical companies can work to develop new products, and Hahn believes the emphasis on speed must remain strong as they work to create new vaccines for new variants of Covid-19 and flu, as well as monkeypox and any future outbreaks of disease. The pre-configured, decentralized trial software will be a key component to ensure these pivotal vaccine trials are conducted as quickly and with large numbers of participants, he said.

“Ironically, the lockdown kind of catalyzed people’s understanding that we can do remote trials,” Khan said. “The industry has made sure that our priorities of maintaining patient safety and data integrity are not compromised by using this new approach.”

Research shows that decentralized clinical trials are also financially beneficial. A study published earlier this year by the Tufts Center for Drug Development Research says that for decentralized phase II trials, a one- to three-month reduction in implementation time yields a net financial benefit of up to five times the the initial investment required. For Phase III trials, such savings in implementation time can result in a net benefit that is up to 13 times the initial investment required.

Photo: Warchi, Getty Images

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