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Wednesday, February 21, 2024
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A New-age Clinical Trial Suite to Expedite Medical Innovation

The human knowhow transcends every boundary, and yet it still hasn’t touched on anything more valuable than our ability to grow on a consistent basis. We say this because the stated ability has already served up the world upon some huge milestones, with technology appearing as a major member of the group. The reason why technology enjoys such an esteemed stature among people is, by and large, predicated upon its skill-set, which ushered us towards a reality that nobody could have ever imagined otherwise. Nevertheless, if we look up close for a second, it will become clear how the whole runner was also very much inspired from the way we applied those skills across a real world environment. The latter component was, in fact, what gave the creation a spectrum-wide presence, and consequentially, kickstarted a full-blown tech revolution. Of course, this revolution then went on to scale up the human experience through some outright unique avenues, but even after achieving such a monumental feat, technology will somehow continue to produce the right goods. The same has grown increasingly evident in recent times, and assuming one new healthcare-themed development shakes out just like we envision, it will only make that trend bigger and better moving forward.

Lindus Health, an “anti-CRO” company running radically faster and more reliable clinical trials for life science pioneers, has officially announced the launch of a unified suite, which packs together its proprietary technology with clinical site and CRO services to supplement digital therapeutics (DTx) and digital health trials. Meant to help you conceive quicker, but at the same time, higher quality studies for regulatory approvals and payor access, the stated suite includes a unique virtual/hybrid site offering, powered through Lindus’ own Citrus Clinical Trial software. Talk about the same on a slightly deeper level, though, we begin from the CRO services in play for end-to-end execution. You see, backed by a line-up of DTx experts who have already completed many such studies in the past, these CRO services will be able to cater every phase of digital therapeutics trials, including protocol development, ethics committee submissions, patient recruitment, data management, safety reporting, and more. Making this all the more valuable is how the whole operation is likely to be handled using an exclusive eClinical platform. Next up, we must get into the suite’s promise of delivering technology-driven recruitment services. Set to leverage various different strategies to meaningfully accelerate DTx trials, the offering will further bank upon Lindus’ access to more than 30 million electronic health records (EHRs), as well as an in-house digital marketing team to execute comprehensive multi-channel recruitment campaigns. The given combination of EHRs and a human team, when used across the independent vicinity, has displayed notable success in efficiently screening and enrolling thousands of patients for DTx studies. Moving on, it’s time for us to study a part of the equation where we have clinical site services. Here, Lindus is bringing to the fore an internal site operations team which can execute DTx studies in every context, including single site studies, multi-site studies, traditional strictly-on-premise studies, outright virtual, or even a hybrid form of studies. In practice, the stated execution will be achieved by engaging with highly experienced principal investigators (PIs) in DTx, Clinical Research Coordinators (CRCs), and other site personnel, to proactively manage any administrative, protocol-related, or miscellaneous activities, thus ensuring a seamless trial conduct at the site level.

“Our new offering for the DTx market will eliminate the guesswork and hurdles sponsors in this space face head-on when trying to run their own clinical studies. It’s exciting to be able to leverage all our experience in the DTx space and deliver that as an efficient DTx specific CRO operation that includes software, site, and CRO services package that aims to deliver DTx studies faster and more efficiently in hopes of getting these innovative treatments to market,” said Anthony Brogno, Director of Clinical Operations at Lindus Health.

Hold on, we still have a few bits left to unpack, considering we haven’t discussed in detail Lindus Health’s Citrus Complete eClinical Platform. This particular platform marks a major detail due to its knowhow in offering EDC, CTMS, data collection, and site management tools, tools that have actually proven they can take and distribute data for DTx studies in CDISC SDTM format at the click of a button. Finally, we round off the highlights with an all-important mention of Lindus’ extensive experience in DTx and medical device regulatory pathways. You see, thus far, the company has concluded 17 successful trials involving digital therapeutic products within 12 therapeutic locations, including multiple trials for FDA 510 (k) and De-Novo submissions. More on that would cover the company’s wider track record of completing more than 90 trials till date, trials which enrolled well over 6,000 patients. Interestingly enough, a good chunk of these studies were actually dedicated towards the DTx domain so to test interventions for a wide range of conditions, such as diabetes, social anxiety, myopia, and tinnitus etc. Coming back to the speed element long associated with the company, Lindus has proven to expedite clinical studies by almost three times, in comparison to traditional CROs.

 

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