Innovative CRO Transforms Medical Device Trials with Comprehensive Solutions

Introduction to Lindus Health's Revolutionary CRO

Lindus Health is shaking up the world of clinical trials with their unique 'All-in-One Medical Device CRO' offering. This new service is crafted to make medical device clinical trials faster, more efficient, and more reliable.

Expansive Participant Recruitment

With over 11,000 participants enrolled in trials across the US, UK, and Europe, Lindus Health demonstrates unmatched proficiency in recruiting for medical device trials. Their recruitment approach utilizes a vast database of over 30 million electronic health records (EHRs) and innovative digital marketing strategies.

Diverse Therapeutic Expertise

The 'All-in-One Medical Device CRO' incorporates Lindus Health's experience across diverse therapeutic fields, including neurology, ophthalmology, cardiology, respiratory, and more. They manage trials for a wide array of devices, from low-risk Class I devices to moderate-risk Class II devices and beyond.

Regulatory Mastery

What sets Lindus Health apart is their expertise in navigating complex regulatory pathways. They are well-versed in FDA 510(k) and De Novo submissions as well as Conformité Européenne (CE) marking, which are critical for bringing new medical devices to market.

Technology Integration with Citrus™

At the heart of their operations is their proprietary eClinical technology named Citrus™. This advanced platform supports all facets of clinical trial execution, from patient enrollment to data capture and monitoring, ensuring streamlined and efficient trial processes.

Comprehensive Site Capabilities

Lindus Health's network includes both virtual/hybrid sites and physical community sites, providing flexible and comprehensive support for clinical trial needs. This diverse site capability enables quicker participant enrollment and more efficient trial management.

Accelerating Study Milestones

Leveraging their tech-driven approach and unique capabilities, Lindus Health is able to achieve study milestones significantly quicker than traditional CROs. Their all-encompassing service package ensures trials are conducted smoothly and efficiently.

Patient-Centric Approach

Central to their model is a focus on patient experience. Each trial is designed to ensure participants are well-educated and supported throughout, addressing the specific needs and considerations of medical device use.

Expert Advisory Board

Lindus Health's initiatives are strengthened by the guidance of an esteemed advisory board, featuring industry leaders like Robert Langer, co-founder of Moderna. This board helps steer the company's vision and ensures adherence to the highest standards of clinical research.

Driven to Innovate in Medical Research

With their trailblazing approach, Lindus Health aims to revolutionize the field of medical device clinical trials. Their commitment to efficiency, reliability, and patient satisfaction sets a new standard in the industry, helping bring innovative medical devices to market more swiftly.