NEW
YORK, June 27, 2024 /PRNewswire/ -- Lindus
Health, the "anti-CRO" running radically faster, more reliable
clinical trials for life science pioneers, has unveiled their
all-encompassing contract research organization (CRO) and
technology solution customized for the execution of medical device
clinical trials.
Lindus Health has enrolled over 11,000 medical device trial
participants to date in the US, UK, and Europe, and has demonstrated consistent
success in executing device studies across virtually all
therapeutic areas, including neurology, ophthalmology,
cardiovascular, respiratory, and more. This covers many device
types including Class I (low-risk) and Class II (moderate-risk)
devices, diagnostics and others, as well as regulatory pathways
such as premarket approval (PMA) and Conformité Européenne (CE)
marking. With the introduction of their "All-in-One Medical Device
CRO," Lindus will accelerate and enhance clinical trials for
medical devices, pulling from their robust resume in device
development.
Lindus Health's new offering integrates traditional CRO services
and comprehensive experience in medical device clinical trials.
Additionally, they have unique recruitment capabilities by
utilizing their database of over 30 million electronic health
records (EHRs) and or in-house digital marketing. This offering
also includes their home-grown eClinical technology, Citrus™.
Lindus offers extensive in-house site capabilities including their
own virtual/hybrid site and physical community site networks. This
all-inclusive package equips medical device sponsors with all the
necessary tools to run their studies under one roof.
Medical device clinical trials follow distinct regulatory
pathways and often require extensive post-market surveillance and
reporting. Lindus Health's offering leverages their expertise in
FDA 510(k) and De Novo submissions and participant monitoring in
device trials alongside their virtual and traditional site
capabilities, multi-channel recruitment approaches, and more. Their
tech-driven approaches to nearly all facets of medical device trial
execution enable them to achieve study milestones quicker and
enroll participants twice as fast as traditional CROs.
"Device trials are highly unique in the endpoints they measure,
the level of support that may be needed to educate participants on
the investigational device, shipping and storage considerations,
and much more," said Anthony Brogno,
Director of Clinical Operations at Lindus Health. "Whether it's a
decentralized or site-based study, our 'All-in-One
Medical Device CRO' allows us to help sponsors navigate the
specialized demands of these trials at every stage while
prioritizing patient experience."
The "All-in-One Medical Device CRO" offering provides medical
device companies with an exhaustive suite of features:
- End-to-end CRO and study management: From startup
through close-out, Lindus Health's clinical operations team handles
all project-related and administrative medical device study
activities.
- Innovative recruitment tactics: Lindus' multifaceted
approach to recruitment involving primary care collaboration,
screening from a network of over 30 million EHRs, digital marketing
capabilities and more help medical device sponsors quickly meet
enrollment timelines.
- Study-specific eClinical software: Citrus™, Lindus
Health's proprietary trial execution technology, houses all the
necessary tools needed to run medical device research in one place,
including the Clinical Trial Management System (CTMS), Electronic
Data Capture (EDC), patient scheduling, eConsent,
IRT/randomization, and more, tailored to each individual
study.
- Medical device and regulatory expertise: The Lindus
Health team, including its advisors, offer expert insights in
medical device trial operations including deep knowledge of
regulatory frameworks and staying current with industry
trends.
- Dedicated site services: Lindus' site operations team
maintains strong rapport with principal investigators (PIs) and
research staff to effectively manage clinical trials of various
models, including single-site or multi-site and virtual/hybrid or
traditional.
"Working with the Lindus Health team has been a game changer,"
said Akash Bijalani, Director of Global Market Access at Aptar, a
global leader in medical technologies. "They have a can-do attitude
and make things happen, going above and beyond the call of
duty."
Lindus Health's "All-in-One Medical Device CRO" is bolstered by
the support of their advisory board, including Robert Langer, co-founder of Moderna, and other
medical device industry experts such as Acacia Parks, Chris Butler, Peter Polos, Jason Bain, and David
Stempel.
Lindus Health is passionate about helping sponsors bring
innovative medical devices to market by streamlining all variables
of the clinical research process while ensuring stellar trial
experiences for both sponsors and participants.
To learn more about Lindus Health's "All-in-One Medical Device
CRO," click here.
About Lindus Health
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. This is achieved through a commercial model that aligns
incentives (fixed-priced quotes per study, with milestone-based
payments), a world-class clinical operations team with its unique
software platform, and access to over 30 million Electronic Health
Records.
Clinical trials are the biggest bottleneck to advances in
healthcare. Lindus Health removes this constraint by handling 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 has raised over $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital,
Presight Capital, Seedcamp, Hambro Perks, Amino Collective and
Calm/Storm.
Lindus Health Media Contact:
Jodi Perkins
Amendola for Lindus Health
jperkins@acmarketingpr.com
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SOURCE Lindus Health