Medable deploys new decentralized testing software for faster vaccine development

medable is arguably the strongest company in the field of decentralized clinical trials. If fundraising is a measure of success, the company raised more than $521 million since its inception in 2012 — significantly more than its competitors, including Curebase, Science 37 and Clara Health.

On Tuesday, Medable bolstered its product offerings by deployment two new software solutions. Softwares is designed to accelerate decentralized vaccine trials so that pharmaceutical companies can better respond to outbreaks of diseases such as monkeypox, Covid-19 and variant influenza. It’s not the first company to launch software designed for decentralized vaccine trials – in fact, Curebase published a platform for home-based Covid-19 vaccine trials in 2020.

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

The “flexible” vaccine trial product includes all of the same tools as the base solution, plus custom digital tools designed to meet the specific protocol needs of a trial. Examples of these custom tools include automated data access via sensors and wearable devices, more complex clinical outcome assessments, and integrations with additional electronic data capture systems and interactive response technology systems. The flexible offering also allows pharmaceutical companies to conduct trials in over 60 languages.

These “off-the-shelf solutions” remove much of the technical build burden for pharmaceutical companies and can reduce trial launch times from more than 12 weeks on average to as little as five weeks, Khan claimed.

“It is important to remember that this is an efficient solution that reduces the time to deploy the technology that supports the operational delivery of vaccine studies – the scientific questions that need to be asked will always have to find an answer,” he added.

The rate of innovation in vaccine research was quite low until the pandemic emerged, according to Khan. Now that scientific innovation is taking off in vaccines (think mRNA technology used in Pfizer and Moderna’s Covid-19 vaccines), it’s time for operational delivery to modernize as well, he said. supported.

The pandemic has demonstrated how quickly pharmaceutical companies can work to develop new products, and Khan believes the focus 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 all future. disease outbreaks. The pre-configured decentralized trial software will be a key part of ensuring these pivotal vaccine trials are conducted as quickly and with large numbers of participants, he said.

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

Research suggests that decentralized clinical trials are also financially advantageous. A study published earlier this year by the Tufts Center for the Study of Drug Development said that for decentralized Phase II studies, reducing deployment time by one to three months yields a net financial benefit of up to five times greater than the initial investment required. For Phase III studies, similar deployment time savings can yield a net benefit of up to 14 times the initial investment required.

Photo: Warchi, Getty Images

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