Breaking News

Spaulding Completes Pharmacology Study

February 20, 2013

Uses 12-bed high-visibility-unit

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.

Related Compliance:

blog comments powered by Disqus
  • Top 25 Pharma and Biopharma Report

    Top 25 Pharma and Biopharma Report

    July 20, 2015
    (Based on 2014 Sales, in $U.S. Millions)

  • Newsmakers: PCI

    Newsmakers: PCI

    Tim Wright, Editor||June 2, 2015
    PCI execs talk about the recent opening of the company’s new North American clinical facility, as well as other trends in the market

  • How Sterilization of Primary Packaging Influences the Results of E&L Studies

    How Sterilization of Primary Packaging Influences the Results of E&L Studies

    Thorsten Sogding, Daniel Canton, Daniel Haines, Uwe Rothhaar, SCHOTT Pharma Services ||June 2, 2015
    As the demands that are being placed on the quality and stability of medications continue to increase, the interactions that take place between the primary packaging container and filled drug product are becoming increasingly important