Our central labs generate more clinical trial data than all other central laboratories combined.
New Info Sheet
Our Approach to Changes in EU IVDR Regulation
On May 26, 2022, the European Union (EU) In Vitro Diagnostics Regulation (IVDR) replaced prior regulations governing how lab-developed tests are regulated for EU and European Economic Area patient management purposes. Labcorp has conducted a comprehensive impact assessment based on our current understanding of available guidance to develop our strategic approach and recommendations for sponsors.
Our new Info Sheet describes how we are serving our sponsors, and strengthening support of clinical trials involving patients from this region.
Journey of a Lab Sample
The life of a sample and the critical data it contains are supported at every step of the sample lifecycle process — from kit production to sample destruction. Watch this video to see how we create high-quality clinical trial sample data, critical for your regulatory submission.
Generating quality data starts with protocol- and visit-specific specimen collection kits that are accurately assembled and reach investigator sites on time. Global logistics experts monitor shipments to assure within stability delivery of specimens.
Consistent results are driven through automation and aligned technology and instrumentation platforms. Standardized processes and procedures are used across our global network of central labs – for specialized testing and for high-volume safety testing.
When studies have been completed, samples can be stored in a Labcorp purpose-built biorepository. Storage for a broad range of specimen types is provided in secure, protected and monitored facilities. Stored sample inventory can be searched, requested and shipped for further testing needs.
Extract the most value out of our globally integrated central laboratory network with the help of our scientific and operational experts.
Ensure specimen safety and integrity in our purpose-built biorepository backed by fully redundant power supplies and auditable tracking systems throughout the chain of custody.
Use best-in-class customized, bar-coded, visit-specific specimen collection kits with the confidence they’ll be delivered on time to investigator sites. And rely on our globally-located team of more than 50 logistics experts for contingency plans that help assure on-time and in-stability shipments.
View individual test results, monitor trends, track sample shipments, confirm site communications, order kits and access version-controlled laboratory manuals—all through the Labcorp Lab portals.