Case study

17 Mar 2021

Flexibility, Trust, & Partnership: How TFS delivered a complex type 1 diabetes study on time despite unexpected challenges


Overview

In clinical trials, we know to expect the unexpected. Navigating issues with patient recruitment, retention, regulatory, protocol amendments, and more is where we excel at TFS. When a client asked for our help to run their Phase IIb Type 1 diabetes study, we knew our extensive diabetes expertise and experience in the proposed countries of Sweden, Spain, and the Czech Republic would be an asset. We didn’t know there would be challenges no one could predict, like a global pandemic. But unforeseen challenges have never diminished our drive to deliver at TFS — if anything, they inspire us to succeed more.


    Study Specifics

    Primary Endpoint: Change in C-peptide during a Mixed Meal Tolerance Test between baseline to 15 months
    Key Secondary Endpoints:

    • Change in insulin-dose-adjusted HbA1c between baseline and 15 months
    • Change in Hemoglobin A1c between baseline and 15 months
    • Change in daily exogenous insulin consumption between baseline and 15 months

    Regions: Sweden, Spain, Czech Republic, and the Netherlands
    TFS Services: Full service
    Indication: Metabolic Disorders: T1D
    Drug Class: Investigational
    Study Phase: IIb
    Number of Sites: 18
    Patient Population: 106 planned (109 actual)
    Study Duration: 3, 5 years First-Subject-In to Last-Subject-Out

    See Other Case Studies

    TFS involved in European global customer’s pre-lau...

    TFS was requested to prepare and conduct a Late Phase global proposal to support the pre-launch activities of two pro...

    Read more

    How TFS Strategic Resourcing Solutions deployed a ...

    Given the catastrophic spread of COVID-19, the search for safe and effective therapies has taken on an unpreced...

    Read more

    TFS & a Global Biotech Company

    As clinical trials grow increasingly complex, timelines shorten, and R&D costs soar. Today’s biopharmaceuti...

    Read more