Case Study

Supporting Multiple Global Gene Therapy Studies For Rare Diseases

Cell Gene Technology

A long-term client called upon the Veristat team for help conducting two investigational Phase I/II studies. These global studies focused on proving the safety and efficacy of gene therapy for two rare genetic disorders. Working side-by-side with the client, our cell and gene therapy experts addressed many complicated challenges – including site start-up issues, stringent regulatory requirements, and the logistics of handling highly sensitive genetic material.

Study Demographics

Rare Disease Global Trials - Multiple Phase I/II studies across the US, Canada, Australia and Israel

Primary Services Provided:

  • Regulatory Consulting
  • Adaptive Design Planning
  • Project Management
  • Monitoring
  • Biometrics
  • Data Management
  • Medical Monitoring
  • Safety Oversight
  • Medical Writing
  • Submissions
VIEW THE CASE STUDY!
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