Case Study

Full Service Support For A Gene Therapy Trial

gene therapy

A clinical-stage biotechnology start-up asked Veristat to run complex US and EU trials of their unique gene therapy. Veristat brought invaluable global capabilities and expertise to a small client team tackling their first clinical stage program without the large infrastructure or resources to conduct studies in this space themselves. Our end-to-end support started at Phase I and will continue into post-marketing and regulatory follow-up.

Study Demographics

Rare Pediatric Global Trial:
Patients from Europe and US, each with central sites and local hospitals

Primary Services Provided:

  • Project management
  • Clinical monitoring
  • Medical monitoring
  • Pharmacovigilance
  • Data management
  • Regulatory affairs
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