Recruitment strategies, eClinical software, regulatory knowledge, and study management are all included in the package.
To enhance the execution of medical device clinical trials, Lindus Health has introduced its comprehensive technological solution and contract research organization (CRO).
To date, the company has recruited over 11,000 participants in medical device trials in the US, UK, and Europe. It has also consistently shown success in carrying out device studies in almost every therapeutic area, including respiratory, cardiovascular, ophthalmology, and neurology. Class I (low-risk) and Class II (moderate-risk) devices, diagnostics, and other device categories are covered, along with regulatory channels including premarket approval (PMA) and Conformité Européenne (CE) certification. By using its experience in device development, Lindus will expedite and improve clinical trials for medical devices with the launch of the “All-in-One Medical Device CRO.”
The new product from Lindus Health combines extensive knowledge of medical device clinical trials with standard CRO services. By leveraging its database of more than 30 million electronic health records (EHRs) and/or internal digital marketing, the company also claims exceptional recruiting capabilities. Citrus, the company’s in-house eClinical technology, is also included in this offering. Lindus provides a wide range of in-house site capabilities, such as its own physical community site networks and virtual/hybrid sites. Sponsors of medical devices can operate their research under one roof with all the resources they need thanks to this comprehensive solution.
Clinical trials for medical devices must adhere to specific regulatory processes and frequently need for substantial post-market reporting and oversight. The product from Lindus Health makes use of its proficiency in De Novo and 510(k) filings to the US Food and Drug Administration, participant monitoring in device trials, virtual and traditional site capabilities, multi-channel recruitment strategies, and other areas. Lindus Health is able to enroll participants twice as quickly as typical CROs and reach study goals more quickly thanks to the company’s tech-driven approaches to almost every aspect of medical device trial execution.
According to Anthony Brogno, Director of Clinical Operations at Lindus Health, “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.” “Our ‘All-in-One Medical Device CRO’ enables us to assist sponsors in navigating the specific requirements of these trials at every stage while prioritizing patient experience, whether it’s a decentralized or site-based study.”
Medical device businesses can benefit from a range of features offered by the “All-in-One Medical Device CRO” package. These features include:
Complete CRO and study management: Lindus Health’s clinical operations team manages all project-related and administrative medical device study tasks from the beginning to the finish.
Creative recruitment strategies: Medical device sponsors can fulfill enrollment deadlines more rapidly with Lindus’s multimodal approach to recruitment, which includes primary care collaboration, screening from a network of over 30 million EHRs, digital marketing capabilities, and more.
Particular to a study, eClinical software: All the resources required to conduct medical device research are centralized in Citrus, a proprietary trial execution technology developed by Lindus Health. These resources include the Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), patient scheduling, eConsent, IRT/randomization, and more, customized for each individual study.
Medical device and regulatory expertise: The Lindus Health team, along with its advisers, provides in-depth understanding of regulatory frameworks and keeps abreast of industry developments in order to provide expert insights in medical device trial operations.
Dedicated site services: To efficiently administer clinical trials of different models, including single-site or multi-site, virtual/hybrid or traditional, Lindus’ site operations team cultivates strong relationships with principal investigators (PIs) and research personnel.
“Collaborating with the Lindus Health group has revolutionized the industry,” stated Akash Bijalani, Global Market Access director at Aptar, a company that develops medical technology. “They go above and beyond the call of duty with a can-do attitude and make things happen.”
As an anti-CRO, Lindus Health conducts trials for life science innovators at a significantly faster and more reliable pace, enabling the speedier delivery of revolutionary cures to patients. This is made possible by a commercial approach that aligns incentives (fixed-price quotes per research, with payouts depending on milestones), a top-notch clinical operations staff, access to over 30 million electronic health records, and a unique software platform. In order to address a variety of ailments, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome, and insomnia, Lindus Health has conducted more than 90 trials in the US, the UK, and Europe to date. Investors include Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective, and Calm/Storm have contributed more than $24 million to the company.
