NEW YORK, Apr 25, 2024 /PRNewswire/ -- Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials for life science pioneers, has released a comprehensive contract research organization (CRO) offering tailor-made for sponsors looking to bring diagnostic products to market.

Lindus Health has enrolled over 30,000 patients in diagnostic trials to date across the US, UK, and Europe, and has consistently proven success in running clinical trials across a variety of different diagnostic products therapeutic areas spanning oncology, infectious disease, respiratory, women's health, and more. With the  introduction of the "All-in-One Diagnostics CRO, Lindus will elevate its diagnostics clinical trials by leveraging its expertise in the testing, monitoring, and biomarker identification of indications across nearly all therapeutic areas and addresses the challenges associated with recruiting and managing data for very large patient studies.

The new offering combines expert CRO services and extensive experience in diagnostic clinical trials with their repository of over 30 million electronic health records (EHRs) and home-grown internal eClinical platform, Citrus™, to provide diagnostics sponsors with everything they need to conduct research all in one place.

Many diagnostics validation clinical trials require upwards of tens of thousands of patients to be recruited in short periods of time, which can be achieved with Lindus' new offering. Their primary care and proprietary, specialty network databases, along with in-house direct-to-patient marketing and remote participation tools, helps sponsors recruit patients two times faster.

"Diagnostics studies have unique challenges that are poorly served by traditional CROs, who approach these studies much like a drug trial, and therefore fall short in delivering studies on time and on budget," said Michael Young, Co-Founder at Lindus Health. "These studies require specific expertise in validating products against a standard of care and also have very demanding and unique recruitment challenges with some studies requiring thousands of patients. Most CROs don't know how to handle studies at this scale except through, driving immense cost and trial complexity."

Diagnostics sponsors can benefit from the following features as part of the "All-in-One Diagnostics CRO" offering:

• CRO and trial management solutions: From protocol development and patient recruitment through data delivery, Lindus Health's clinical operations team possesses deep knowledge in all facets of diagnostics clinical trials.
• Bespoke trial management technology: Citrus™, Lindus Health's proprietary eClinical software tailored to each study, houses all the necessary technologies needed for trial execution, including the Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eConsent, patient scheduling, eConsent, and much more.
• Large-scale recruitment capabilities: A variety of recruitment tactics are used to accelerate patient enrollment, including Lindus Health's primary care network of over 30 million EHRs and an in-house digital marketing team for social media advertising campaigns.
• Expansive knowledge in diagnostics and regulatory pathways: With a track record of submitting numerous trials for FDA 510(k) and De Novo submissions, Lindus Health's expert diagnostics team stays abreast of industry developments and is experienced in regulatory submissions for diagnostics products.
• Exceptional site services and network: Lindus Health's dedicated site operations team fosters strong relationships with principal investigators (PI) and research staff and effectively carries out trials of various models, from single- to multi-site as well as remote/hybrid and traditional settings. Sites are deployed across the company's primary care and specialty care network depending on the needs of the study population.

"With the appointment of Lindus Health, our US market access program is well underway to achieve our goal of obtaining regulatory approval for the initial pre-surgical market in the U.S. for our ovarian cancer blood test," said Richard Allman, CEO of CLEO Diagnostics, an ovarian cancer diagnostics company. "We are appointing high-caliber partners that we believe will help us deliver important ovarian cancer detection technology to improve the health outcomes for women."

Lindus Health's roster of diagnostics expertise extends to its advisory board, including Bob Langer, co-founder at Moderna and institute professor at MIT and Alessandro Falcone, Executive Director of Breast Cancer Oncology R&D Strategy at AstraZeneca.

Lindus Health is devoted to pioneering exceptional diagnostics research, offering efficiency and versatility to provide exceptional clinical trial experiences for both sponsors and patients.

To learn more about Lindus Health's "All-in-One Diagnostics CRO", 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.

To date, ‍Lindus Health has 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.

Lindus Health has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.

Press Contact:
Jodi Perkins
Amendola Communications
JPerkins@acmarketigpr.com
847-508-0877

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SOURCE Lindus Health