Case study

16 Dec 2020

Rescue of 'At-Risk' Trial H5N1 Vaccine Study / Healthy Volunteer Population


Overview

The complexities of coordinated enrollment to meet or exceed timelines are inherent with vaccine trials. Equally essential is the maintenance of high retention rates for quality data results. For this H5N1 Vaccine Study, the initial CRO was unable to accept the contract terms of the Sponsor. The trial execution was further delayed by that CRO’s proposed Investigator Meeting 10 weeks from the contract approval.


    Challenges

    • No information was transferred from the previous CRO
    • The study Sponsor had selected an Immunology Lab prior to the assay being validated (the selected lab was unable to validate the assay)
    • TFS had to revisit all pre-identified Alliance For Multispecialty Research (AMR) sites
    • Renegotiation of the Sponsor contract & investigator contracts required

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