• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Vince & Associates, FDA partner on opioids study

Vince & Associates, FDA partner on opioids study

October 26, 2015
CenterWatch Staff

Vince & Associates Clinical Research has been awarded a contract with the FDA Office of Generic Drugs (OGD) to conduct a clinical pharmacology pharmacokinetic (PK) study of opioids manipulated via milling procedures.

In the study-specific contract, Vince & Associates is responsible for conducting the opioid PK study and providing the necessary support services including study design, protocol development, clinical operations, data management, biostatistics, bioanalytical analysis and medical writing.

The objective of the study is to evaluate factors that affect the bioavailability of milled opioid drug products following nasal snorting. The outcome of the study may help in determining critical study design parameters when comparing deterrence of nasal abuse between a generic and its Reference Listed Drug.

“We are eager to partner with the FDA to help address agency concerns about the manipulation of opioid products. Vince & Associates is uniquely qualified to conduct this trial as our Principal Investigators have extensive substance abuse clinical knowledge and are industry leaders in the conduct of substance abuse trials,” said Dr. Brad Vince, CEO and medical director at Vince & Associates Clinical Research.

The new deal does not mark the first time Vince & Associates has worked with the U.S. government on clinical research trials. In 2012, the company was awarded a five-year, $10 million contract with the National Institute on Drug Abuse, as well as a separate five-year, $5 million contract with the FDA.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing