WEST BEND, Wis., Feb. 19, 2013 (GLOBE NEWSWIRE) — Today, 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.
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.
Spaulding Clinical Media Contact:Kathy FordeSr. Director of
MarketingTel: (414) 303-1912Email: kathy.forde@spauldingclinical.com
