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CASE STUDIES

01

Regulatory QA + PRoject Oversight (Oncology) - Immunomedics

Phase IIb/III oncology study; oversight of ~89 study sites (U.S. footprint referenced in internal materials).

Context

  • Phase IIb/III oncology study across ~89 U.S. sites

  • Multi-vendor environment with monitoring backlog

  • Paper-based processes and documentation gaps

  • Need for audit readiness and CAPA governance

Bracane Actions

  • Conducted SWOT assessment and gap analysis

  • Deployed SWAT CRA team to stabilize monitoring

  • Implemented issue trending and CAPA oversight

  • Led audit readiness planning and FDA inspection support

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Results

  • 3-month rescue engagement expanded to 3 years (2018–2021)

  • Stabilized multi-site monitoring and vendor oversight

  • Strengthened inspection readiness and 483 response support

  • Supported program through successful product launch

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