NEW YORK, Feb. 13, 2025 /PRNewswire/ -- Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials, has announced their collaboration with the Clinical Data Interchange Standards Consortium (CDISC), to accelerate the generation of standardized concepts using AI. CDISC is an organization that develops data standards to streamline the collection, sharing, and analysis of clinical trial data on a global scale.
CDISC is collaborating with Lindus Health, which is utilizing its proprietary AI technology, to accelerate the generation of Biomedical Concepts across both the CDISC Foundational Standards as well as the Therapeutic Area Standards. The traditional approach to this process is highly labor-intensive and time-consuming, often requiring advanced expertise in clinical research standards, medical terminology, and data modeling to generate just a few Biomedical Concepts. Lindus' AI-driven solution has the potential to dramatically streamline this process, enabling the generation of a significantly greater number of Biomedical Concepts with remarkable efficiency.
Clinical trial data submitted to several regulatory agencies, including the U.S. Food and Drug Administration (FDA), must adhere to CDISC standards. CDISC actively collaborates with regulatory agencies to refine standards, ensuring that clinical trial data is structured, interpretable, and consistent across different submissions. CDISC's strategic initiative to develop uniform terminology for capturing clinical observations through Biomedical Concepts will expedite data analysis, sharing, and regulatory review, ultimately advancing the pace of medical innovation and collaboration.
CDISC Biomedical Concepts ensure consistency in data collection, linking information across the data pipeline, and seamless sharing across studies. Large language models (LLMs) are now making it easier to create Biomedical Concepts, helping researchers record and share data with standardized terminology. This pipeline is designed to work across all therapeutic areas, speeding up the creation of these essential concepts while upholding data standards.
"Our partnership with CDISC showcases our commitment to eliminating manual, slow processes in clinical research," said Meri Beckwith, co-founder of Lindus Health. "We're humbled to have the unique opportunity to improve data standards for the entire industry with AI, and we can't wait to see what we accomplish together."
"R&D has entered a transformative new era driven by AI and other advanced technologies that enhance clinical research," said Peter Van Reusel, CDISC Chief Standards Officer. "As we grow our library of Biomedical Concepts to enable our 360i vision of end-to-end connected standards, our collaboration with Lindus Health is a key step in accelerating that work while ensuring data quality and harmonization at scale, paving the way for long-term efficiency as clinical trial data becomes increasingly more complex."
Lindus Health is applying AI and other advanced technologies to optimize key areas of clinical operations, including protocol development, study design, central monitoring, and much more. To learn more about how the company is creating efficiencies in the clinical trial space, click here.
About Lindus Health
Lindus Health is an anti-CRO running radically faster, more reliable clinical 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 40 million Electronic Health Records.
Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint through end-to-end execution of clinical studies driven by technology and forward-thinking approaches to clinical operations.
To date, Lindus Health has delivered clinical 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 $80M from investors including Peter Thiel, Balderton, Creandum, Firstminute Capital, and Seedcamp.
About CDISC
Clinical Data Interchange Standards Consortium (CDISC) creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the European Medicines Agency (EMA) and China National Medical Products Administration (NMPA) and adopted by the world's leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has an invaluable impact on global health. CDISC is a 501(c)3 global nonprofit charitable organization with thousands of partners, volunteers, and member organizations around the world.
Media Contact:
Jodi Perkins
Amendola for Lindus Health
[email protected]
SOURCE Lindus Health
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