BOOK A MEETING
NEW YORK, NY, Feb. 1, 2024 – 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:
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.
To learn more about Lindus Health’s offering for the DTx market, click here.
Lindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. Lindus Health does this thanks to a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), marrying a world-class clinical operations team with its unique software platform, and access to 30 million Electronic Health Records. Clinical trials are the biggest bottleneck to advances in healthcare and by removing this constraint they aim to improve health for everyone. They handle the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.
Lindus Health has to date delivered more than 90 trials across the US, UK and Europe to tackle a range of conditions including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia.
The company was named after James Lind, who pioneered the first clinical trial and treatment for scurvy, and co-founded by Michael Young, a former Special Adviser to the UK Prime Minister on Life Sciences, and Meri Beckwith, a former life sciences investor.
The company has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.
Running Effective DTx Studies in EU Markets, and Considerations for Cross Country Data Acceptance
As more innovators join the digital therapeutics (DTx) landscape, understanding the intricacies of running clinical trials in Europe becomes increasingly essential. Tune in to discover how CROs in the DTx space help sponsors navigate these hurdles to successfully conduct clinical trials, delivering essential digital health interventions to patients faster.
Interview: Robert Langer backs Lindus Health’s "anti-CRO" strategy
Robert Langer and Lindus Health co-founder, Meri Beckwith, sat down for a Q&A session to discuss their new partnership and future direction of the company.