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COVID-19: Clinical Research Products Development Center (CRPMC)

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 75N93020C00032-0-9999-2

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Key facts

  • Disease

    COVID-19

  • Start & end year

    2020.0
    2021.0

  • Known Financial Commitments (USD)

    $1,196,744

  • Funder

    National Institutes of Health (NIH)

  • Principal Investigator

    . NEERAJA PUTTA

  • Research Location

    United States of America

  • Lead Research Institution

    FISHER BIOSERVICES, INC.

  • Research Priority Alignment

    N/A

  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Therapeutics logistics and supply chains and distribution strategies

  • Special Interest Tags

    N/A

  • Study Type

    Not applicable

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Not Applicable

  • Vulnerable Population

    Not applicable

  • Occupations of Interest

    Not applicable

Abstract

NIAID has a requirement for the management and operation of a Clinical Research Products Management Center (CRPMC) to support NIAID-sponsored clinical research trials both domestically and internationally. This contract will provide pharmaceutical services and study product management by providing a cGMP-compliant facility, receipt, storage, labeling, packaging, repackaging, shipping, acquiring, and disposition of study products. This contract will provide cognitive pharmaceutical services including evaluating draft protocols; reviewing site pharmacy monitoring reports and maintaining a site audit pharmacy report database; providing study product storage and stability information, guidance in research pharmacy practice and study product management activities to clinical site pharmacists; and conducting Current Good Manufacturing Practice (cGMP) audits of manufacturing facilities. This project will support study product management and distribution of the study products for COVID-19 clinical trial A5401 (ACTIV-2 Outpatient Monoclonal Antibodies And Other Therapies).