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Spaulding Clinical Research, a change agent in the clinical research and medical device industries, announced that the company has completed a First-In-Human (FIH) study using their dedicated, 12-bed FIH High-Visibility-Unit (HVU). The study was conducted for a biotech Sponsor developing a non-opioid analgesic.
"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, "states Daniel Selness, General Manager and Sr. Vice President of Clinical Research at Spaulding.
The study Sponsor stated this was an "ideal place to conduct this study" and was very impressed with the operational flow, as well as the entire infrastructure supporting the HVU including backup power, and close proximity to required processing areas. The unit is staffed by ACLS-certified research staff who are well-trained on the emergency response plan and equipment.
Spaulding's decentralized study 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.