Spaulding completes FIH study using 12-bed FIH High-Visibility-Unit

The study was conducted for a biotech sponsor developing a non-opioid analgesic.

Spaulding Clinical Research general manager and senior vice president Daniel Selness said subject safety is the firm’s primary goal 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," Selness added.

Spaulding has conducted the study through a decentralized approach, where all dosing, blood draws and procedures are performed at the bedside, translates efficiently into the 12-bed, HVU with glass sliding doors and a glass-enclosed central nursing station.

Clinical investigators and study staff can view subjects in their rooms from the nursing station, as well as monitor their 12-lead ECGs, pulse oximetry and vital signs continuously.

All study data is fully integrated into a customized Clinical Pharmacology Electronic Data Capture (EDC) solution, which can be remotely viewed by the study sponsor in real-time.