About Us

The Alpha Clinic leadership and staff help navigate regulatory and clinical trials startup for regenerative medicine research conducted across the UCSF campus. 

The UCSF Alpha Clinic provides infrastructure support to accelerate the startup time for cellular therapy trials. Our goal is to ensure continuous movement of all startup and project milestones. We do this by providing the following:

  • Regulatory compliance support
  • Chemistry Manufacturing Controls (CMC)/Quality Assurance (QA) consultation
  • Site startup operations
  • Biospecimen logistics
  • Consultations at any point in the clinical development pipeline
  • Project management

Our service components address Investigational New Drug (IND)-enabling studies, IND-authorized studies, and maintenance with local, central/commercial, and reliance Institutional Review Boards (IRBs). We provide consulting to assist with budget development and contract negotiations, cellular drug product collection, handling and processing logistics, and overall protocol development.

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