Case study: Repositioning first-in-human development at speed
An FDA regulatory hurdle threatened to delay a first-in-human autoimmune program by over 8 years. Parexel's globally integrated scientific and regulatory team identified an alternative pathway, unified safety protocols, and eliminated bottlenecks—restoring the program to its original timeline.
The result: study initiation in just 3 months with zero safety findings at first subject, first dose.
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