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 senior 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.
To view pictures of the dedicated, HVU or to review Spaulding Clinical 2012 study metrics, visit www.spauldingclinical.com.
About Spaulding Clinical Research, LLC
Spaulding Clinical Research, LLC (www.spauldingclinical.com) a change agent in the clinical research and medical device industries, is focused on driving perpetual value for their clients through technology and process innovation that delivers speed, unprecedented quality and lower costs.
Spaulding Clinical Research operates a 105-bed clinical pharmacology unit with 96, 12-lead ECG, telemetry beds in West Bend, Wisconsin, USA. The facility is paperless, using a customized Phase I Electronic Data Capture system with bi-directional interfaces to clinical lab, bedside devices and telemetry. Spaulding Biometrics provides full-service biostatistics, data management and medical writing services.
As a Phase I-IV centralized cardiac safety provider, Spaulding Clinical offers project management, expert cardiologist ECG over-read and a complete suite of state-of-the-art equipment provisioning, including the Spaulding webECGTM diagnostic 12-lead ECG Management Solution with the purpose-built Spaulding Model 1000iQ Electrocardiograph.