Clinical Trials

Lindus Health introduces “All-In-One CRO for Digital Therapeutics”

Lindus Health, an “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, announced the launch of its unified technology, site services and CRO services package for digital therapeutics (DTx) and digital health trials. This will enable sponsors to run radically faster, higher quality studies for regulatory approvals and payor access.

Lindus Health’s new offering for the DTx market bundles the services of an experienced CRO in DTx. This includes a unique virtual/hybrid site offering, all underpinned by Lindus’ internal Citrus clinical trial software built to run any DTx study from startup and recruitment to data delivery. Lindus has proven success in executing trials within this domain, having run 17 DTx studies in 12 disease indications across the US, UK, and EU and enrolling over 3,000 patients. This offering is intended to produce a true “one-stop-shop” experience for everything needed to run a DTx clinical trial. Available now, this one-of-a-kind bundle of eClinical software, site capabilities, and CRO services empowers DTx sponsors to accelerate their clinical trials as a result of the following features:

  • CRO services for end-to-end execution: Lindus Health are experts in the DTx space, having run a multitude of these studies across many countries. They offer a full suite of study execution services at every phase of digital therapeutics trials, including protocol development, ethics committee submissions, patient recruitment, data management, safety reporting, and more, through a singular eClinical platform.
  • Technology-driven recruitment services: Lindus Health employs a variety of different strategies to accelerate DTx trials. With access to over 30 million electronic health records (EHRs) and an in-house digital marketing team to execute multi-channel recruitment campaigns, Lindus Health has proven success in screening and enrolling thousands of patients for DTx studies faster than traditional CROs.
  • Clinical site services: From single- to multi-site studies, and traditional to virtual or hybrid sites, Lindus Health’s internal site operations team is staffed to execute DTx studies from top to bottom. This includes engaging with highly experienced principal investigators (PIs) in DTx, Clinical Research Coordinators (CRCs), and other site personnel to manage any administrative, protocol-related, or miscellaneous activities to ensure seamless trial execution at the site level.
  • Citrus Complete eClinical Platform: Internally developed eClinical platform including EDC, CTMS, data collection, and site management tool with tested experience in collecting and delivering data for DTx studies in CDISC SDTM format at the click of a button.
  • Deep expertise in DTx and medical device regulatory pathways: Lindus Health’s clinical operations team has experience running 17 trials involving digital therapeutic products within 12 therapeutic locations, including multiple trials for FDA 510 (k) and De-Novo submissions.

Collaborating with the right CRO backed by extensive experience in DTx studies is crucial for the success of these trials, as there are a number of considerations unique to conducting a DTx trial. Lindus Health’s all-encompassing digital therapeutics offering avoids the need for sponsors to worry about responsibilities such as selecting vendors for various trial management technologies and identifying and engaging with sites for participation. The company’s eClinical software includes the full package of tools to run a clinical trial. The impact is harmonious data access between the electronic data capture (EDC), clinical trial management system (CTMS), visit scheduling, data collection tools (eConsent, ePRO, etc.) and more. This unified technology offering coupled with a full-suite of DTx specific CRO services sets DTx sponsors up for success when launching and conducting trials for their innovative and potentially life-changing therapies.

Lindus Health has established themselves as highly reputable in accelerating the development of digital therapeutics. With the support of DTx advisors such as Acacia Parks and their partnership with the Digital Therapeutics Alliance (DTA), the company stands out as an innovative and experienced CRO within this market segment. The company has enrolled more than 6,000 patients across over 90 clinical trials to date, with a significant proportion within the DTx domain. These trials have tested DTx interventions for a wide range of indications such as diabetes, social anxiety, myopia, tinnitus, and more.

Anthony Brogno, Director of Clinical Operations at Lindus Health, said: “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.

Digital therapeutics are evidence-based software interventions designed to prevent, manage, or treat various medical disorders and diseases. These therapies can be utilized through mobile applications, wearables, or online platforms to manage and treat a wide array of chronic conditions and can be used in complement to or in lieu of pharmaceutical medications and medical devices.

Lindus Health’s “All-In-One CRO” offering enables DTx companies to achieve study milestones faster through their tech-forward and patient-centric approach to executing clinical trials.

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