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.
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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.”
SOURCE: PRNewswire