Supply chain disruptions and manufacturing shortages have significantly affected the clinical trial industry, an issue exacerbated by an unprecedented demand for clinical trial kits.

Labcorp was approached by a client who wants to establish European Food Safety (EFSA) Approved import tolerances for a crop protection product (CPP) not registered in Europe and widely used on bananas.

Labcorp was approached by a client who, as part of a regulatory submission, needed to create a laboratory-scale test setup for conducting post-harvest fumigation studies of multiple commodities at different controlled temperatures.

The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015.

This case study outlines how the team supported the sponsor's needs - and handled unexpected volume surges - to meet regulatory compliance and serve as more than a partner.

A startup company (with the help of two innovative physicians) developed a tool that provides a safer, more effective way to alleviate a common orthopedic condition. Although early funding came at a cadence that kept progress moving steadily ahead, rounds for managing the entire life cycle to reach commercial distribution were relatively small.

A medical device manufacturer conducted a successful randomized IDE clinical trial, but at the time of study closure they decided not to file the Premarket Approval (PMA) application for business reasons. However, five years later, the business climate had improved and the company proceeded with its PMA application.

At Labcorp, we strive to be more than just a partner. Our robust knowledge of mobile healthcare includes over 10 years of experience in providing in-home services, site support and central pharmacy solutions that are solely dedicated to the support of clinical trials.

All governments are keen to ensure that the chemicals produced, manufactured and used within their countries are safe for consumers and used appropriately. The 2007 European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation has become a model globally and is hazard based. In contrast, the U.S.

Inhalation studies are mandatory in many regulatory situations where it is critical to understand the potential risk posed by respiratory exposure to a chemical or agrochemical. As you prepare for the preliminary characterization trials required by regulators, read our answers to 20 frequently asked questions.