Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, has officially announced the launch of a brand-new all-encompassing contract research organization (CRO) and technology solution which is customized for the execution of medical device clinical trials. According to certain reports, the stated offering works by integrating traditional CRO services and comprehensive experience in medical device clinical trials. Banking upon a database of over 30 million electronic health records (EHRs) and in-house digital marketing, it also packs together Lindus’ home-grown eClinical technology, Citrusâ„¢. This whole technological setup, on its part, empowers the solution to offer extensive in-house site capabilities including their own virtual/hybrid site and physical community site networks. Apart from that, it also bestows medical device sponsors with all the necessary tools to run their studies under one roof. Talk about the given value proposition on a slightly deeper level, we begin from its end-to-end CRO and study management facility, which ensures that everything from the startup through close-out is taken care of by Lindus Health’s clinical operations team, including all project-related and administrative medical device study activities. Next up, we must get into the solution’s innovative recruitment tactics that leverage the company’s multifaceted approach to recruitment, an approach that is markedly made up of primary care collaboration, an ability to screen from a network of over 30 million EHRs, digital marketing capabilities, and more, to help medical device sponsors quickly meet enrollment timelines.
“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.”
Then, there is the presence of Lindus’ Citrus software, which 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. Joining the concrete prowess in play is the company’s comprehensive medical device and regulatory experience. This translates to the luxury of being able to rely upon Lindus Health team, such as its advisors, who can offer expert insights in medical device trial operations, including deep knowledge of regulatory frameworks and staying current with industry trends. Rounding up highlights would be the solution’s dedicated site service. Here, Lindus’ site operations team comes bearing the knowhow to maintain strong rapport with principal investigators (PIs) and research staff so to effectively manage clinical trials of various models, including single-site or multi-site and virtual/hybrid or traditional.
Making the development even more significant is Lindus’ existing research in the context of clinical trials. You see, till date, the company 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. By that, we also refer to 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 more.
“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.”