We were approached by a European company producing a standard herbicide for maize who had been asked by the regulator to conduct a study to provide data to refine the small mammal risk assessment.

More than 350 million people live with over 7,000 identified rare diseases worldwide. Being patient-centric calls for innovation in service (not just technology), particularly for specialized needs associated with rare diseases. Today, along with an increased ability to treat these diseases, we see extra pain points in the patient journey.

Labcorp Drug Development was required to develop a pharmacokinetics (PK) assay. A PK enzyme-linked immunosorbent assay (ELISA) had previously been developed; however, Labcorp recommended that the assay be transferred to Meso Scale Discovery (MSD) format to gain more sensitivity.

Digital transformation is a grand phrase - it can cover technological innovation, data and processes, and even global organizational change yet it doesn't have to be a daunting prospect left to those looking for systemic change at a company level.

We understand the importance of decentralized clinical trial models, which can include hybrid or virtual elements in a study, to enhance the patient experience and increase trial retention.

AACC 2021 -- Clinical studies often involve collection and shipment of serum or plasma samples in frozen conditions from collection sites and multicenter laboratories, to central labs for analysis (Cuhadar et al., 2013).

The Labcorp goal is to create an environment where Innovation and Disruption thrive. By following such a model we are building a platform to "digitize" drug development starting with a patient-first point of view.

In this booklet, you will find requirements described in the ISO 14155:2011.

This case study outlines the unique challenges faced in order to deliver flexible services during the pandemic and the team's innovative solutions to help ensure that pharmacovigilance and patient safety protocols were upheld.

Working within a regulatory demanding industry and getting your product to market is the culmination of a lengthy developmental process.