A major pharmaceutical company was running a global Phase III program and choose the Mobile Clinical Services group at Labcorp Drug Development (Labcorp) to advance their studies. They wanted to collect stool samples from their oncology patients and needed dedicated support to help educate patients on collection and shipment techniques.

Spinal cord injury (SCI) occurring in C through T2 are the most severe injuries requiring a great amount of advance planning, education and on-boarding of sites, and are performed in Level 1 Trauma Emergency Rooms (ERs) in the U.S., and the largest hospitals accepting these critical patients in ex-U.S. countries.

Labcorp has recently completed full-service execution of a Phase I multiple ascending dose (MAD) study in Parkinson's disease (PD) patients. This case study presented a typical set of challenges encountered when executing PD studies, as well as unique challenges pertaining to the specifics of the protocol.

In this case study, we outline key challenges and achievements from a recently completed Phase III study in stroke patients.

A small biopharmaceutical client was developing a higher-dose version of an existing treatment to block symptoms of opioid withdrawal. Since the drug had been on the market for some time, no current testing data were available.

A leading biotechnology client contracted with Labcorp for a human absorption, metabolism and excretion (AME) study using 14C to determine the excretory pathway and metabolite identification and potential enterohepatic recycling.

A mid-sized drug manufacturer was in Phase I clinical trials for a molecule designed to treat adenoviral infection. Their contract manufacturing organization (CMO) predicted a delay in drug production leading to a three- to six-month delay in study start-up.

Patient recruitment represents the biggest challenge in clinical trials.

Most people in our industry are familiar with the "Leaky Funnel" analogy that describes the model where we approach a large number of patients for inclusion in a study, but they leak out of the pipe at every juncture.

In 1848, the most famous Gold Rush in American history began at Sutter's Mill near present-day Coloma, California, shaping the U.S. economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.