Spaulding Clinical Research has completed a First-In-Human (FIH) study using its dedicated, 12-bed FIH High-Visibility-Unit (HVU). The study was conducted for a biotech sponsor developing a non-opioid analgesic.
Spaulding conducted all dosing, blood draws and procedures at the bedside in its 12-bed, HVU with glass sliding doors and a glass-enclosed central nursing station. Clinical investigators and study staff viewed subjects in their rooms from the nursing station, as well as continuously monitored their ECGs, pulse oximetry and vital signs.
"Subject safety is our primary consideration in conducting any Clinical Pharmacology study. As part of our commitment to safety, we designed the High-Visibility-Unit for First-in-Human studies or any study where the compound requires added surveillance or very intensive monitoring," said, Daniel Selness, general manager and senior vice president of Clinical Research at Spaulding.