Effective May 26, 2022, the European Union (EU) In Vitro Diagnostics Regulation (IVDR) replaced the In Vitro Diagnostics Directive. This regulation governs how in vitro diagnostics (IVDs) and lab-developed tests (LDTs) are regulated for diagnostic and EU/European Economic Area patient management purposes.

Building lists of pre-primed patients and using the data can steer clinical trial design, patient identification and faster recruitment into trials.

Generating product value is key to market success. Real-world data (RWD) are the basis to generate the right evidence for your value story-aiming to address the needs of various stakeholders like insurance companies, governmental bodies, medical associations and patient advocacy groups.

Mobile Clinical Services (MCS) are becoming a main pillar in neurology clinical trials. By reducing study burden on patients while also providing support to investigator sites, MCS enables sponsors to conduct trials more efficiently.

Preparing investigator sites for RTE requires agility, efficient processes, creative problem-solving and regional expertise across multiple geographic areas. For each study, we assign a team of Labcorp startup operations specialists responsible for site activations within each proposed country.

Ensuring your product is accepted by regulatory authorities, compliant with classification, labeling and safety standards, and up to date with the latest regulatory changes is a complex process that requires extensive insight on current guidelines.

A biotech company with a global Phase II amyotrophic lateral sclerosis (ALS) trial needed solutions to reduce the burden of their clinical trial for patients.

Globally, endometriosis affects up to 10% of all reproductive-age women. Of these estimated 175-200 million individuals with endometriosis, many experience significant diagnostic delays.

Labcorp Mobile Clinical Services (MCS) has been a crucial enabling solution for studies with challenging patient populations and for studies necessitating participant compliance with the visit schedule.

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