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
