Medable is arguably the strongest company in decentralized clinical trials. If fundraising is a measure of success, the company has raised more than $521 million since its inception in 2012 — significantly more than its competitors, including: cure base, Science 37 and Clara Health.
On Tuesday, Medable made its product offering more robust by: unroll two new software solutions. The software is designed to accelerate decentralized vaccine trials so that pharmaceutical companies can better respond to outbreaks of diseases such as monkeypox, Covid-19, and strains of the flu. It’s not the first company to launch software designed for decentralized vaccine testing – in fact, Curebase released a platform for at-home testing of Covid-19 vaccines in 2020.
Medable’s “core” vaccine testing product includes a preconfigured set of modules that handle things such as pre-trial screenings of participants, electronic consent, television visits, electronic clinical outcome assessments and real-time data reporting. Pharmaceutical companies and clinical research organizations can deploy the core solution in just five weeks, Musaddiq Khan, Medable vice president and head of solutions for therapeutic areas, said in an interview.
The ‘flex’ vaccine research product features the same tools as the core solution, along with custom digital tools designed to meet the specific protocol needs of a trial. Examples of these custom tools include automated data access through sensors and wearables, more complex assessments of clinical outcomes, and integrations with additional electronic data recording systems and interactive response technology systems. The flexible offering also allows pharmaceutical companies to conduct trials in more than 60 languages.
These “turnkey solutions” eliminate much of the engineering build burden for pharmaceutical companies and could shorten trial launch timelines from an average of more than 12 weeks to just five weeks, Khan claimed.
“It’s important to remember that this is an efficiency solution that reduces implementation time for technology that supports the operational delivery of vaccine studies – the scientific questions that need to be asked still need to be answered,” he added.
According to Khan, the rate of innovation in vaccine research was quite slow until the pandemic broke out. With scientific innovation taking off in the vaccine space (think mRNA technology used in Pfizer and Moderna’s Covid-19 vaccines), it’s time to modernize operational delivery as well, he argued.
The pandemic has shown how quickly pharmaceutical companies can work to develop new products, and Khan believes that the emphasis on speed should remain strong when creating new vaccines for new variants of Covid-19 and flu, as well as for monkeypox and possible future disease outbreaks. Preconfigured decentralized trial software will be a key component in ensuring these crucial vaccine trials are done as quickly and with a large number of participants, he said.
“Ironically, the shutdown catalyzed people’s understanding that we can do remote trials,” Khan said. “The industry made sure that our priorities for maintaining patient safety and data integrity were not compromised by using this new approach.”
Research suggests that decentralized clinical trials are also financially beneficial. A study Released earlier this year by the Tufts Center for the Study of Drug Development, it said for decentralized Phase II trials, reducing implementation time by one to three months provides a net financial benefit up to five times greater than the initial investment required. For phase III studies, comparable implementation time savings can yield a net benefit up to 14 times greater than the initial investment required.
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