SSI Strategy

Case Study

Clinical Operations

How we helped a rising biotech with a novel gene therapy product engage with regulators, investigators, and clinical sites as they dosed patients

By The Numbers:

  • 100% Manual Processing
  • 5 sprints in 1 year
  • 7 countries globally
  • 97.5% compliance KPI
  • Trending towards
  • 90% automated AE form intake


  • Small gene therapy organization and a novel drug with potentially serious adverse events and a complex dosing procedure
  • Limited global experience dosing the target patient population and therapy
  • Currently dosing at a single site with challenging investigator
  • Close monitoring by regulatory agencies and ongoing inspections


  • Supported the existing principal investigator to improve the relationship
  • Prepared and guided the clinical site through FDA inspections
  • Revised the protocol to reduce adverse events and improve patient safety
  • Engaged additional clinical sites and investigators to diversify patient dosing


  • Successful FDA inspection with no significant follow-up required
  • Improved relationship with the principal investigator
  • Additional dosing sites prepared, patients screened, and investigators engaged
  • Closer monitoring of CRO leading to reduced expense

View Our Other Case Studies



Medical Affairs Roadmap​

Clinical Development


Digital-Led Biotech Strategy​