• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » TransCelerate BioPharma’s Clinical Trial Comparator Network now active

TransCelerate BioPharma’s Clinical Trial Comparator Network now active

August 7, 2013
CenterWatch Staff

TransCelerate BioPharma has reached its primary milestone in its Clinical Trial Comparator Network initiative. Formed to establish reliable, rapid sourcing of quality drug products for use in clinical trials, the Comparator Network will enable accelerated clinical trial timelines and enhanced patient safety.

In July, a master service agreement (MSA), affirming a mutual commitment to offer secure and rapid supply of comparator drug products for clinical trials, was executed by several TransCelerate member companies. The network is now active and the first network-based transaction has been initiated.

Currently, the mechanisms to acquire clinical trial comparator drugs and co-therapy drugs are inefficient and unpredictable. Unless a specific agreement is in place between biopharmaceutical companies, trial sponsors frequently are unable to secure comparators and co-therapies directly from each other, and therefore must purchase on the open market. This leads to uncertainties regarding the ability to obtain an adequate and timely supply of necessary comparators and can result in supply disruptions. As newer and more sophisticated therapies enter the market, the situation may deteriorate. Difficulty in the sourcing of comparator drugs can result in delays for a clinical study and delay availability of the drug to patients.

"The current process to source and manage comparator drugs and co-therapies can be challenging," said Dalvir Gill, Ph.D., chief executive officer of TransCelerate. "Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs. With the activation of our Comparator Network,  participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and mitigate the risk of counterfeit drugs in that clinical trial."

Terry Walsh, R.Ph., MBA, head of the Comparator Network initiative for TransCelerate, said, "We believe the Comparator Network will provide an infrastructure that improves the primary operating model for the comparator supply chain. Improved access to comparator drug stability and regulatory data will enable member companies to reduce waste by allowing for better management of temperature excursions and facilitate global trials. Member companies also will have the ability to receive detailed demand data, which will facilitate improved supply chain planning and reduce the chance of supply issues for crucial products."

"For the first time, this TransCelerate initiative will allow industry-wide alignment and improved supply chain around comparator drugs for clinical trials that is so critical to enhancing patient safety and improving the efficiency of clinical trials," said Paul Stoffels, M.D., chief scientific officer and worldwide chairman, pharmaceuticals at Johnson & Johnson.

TransCelerate expects more companies to join the Comparator Network.

    Upcoming Events

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

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

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    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 703.538.7600 – Toll free 888.838.5578

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