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Services

Services Provided

  • Strategic input on study design and clinical development planning

  • SAP (Statistical Analysis Plan) review and development

  • Protocol review with statistical input

  • Assistance with vendor selection and review of contract scope and budget

  • Biometrics vendor oversight

  • Sample size calculations and simulation-based scenario planning

  • Review of CRF design and database structure

  • Data quality assessment

  • Develop cross-functional data cleaning plans aligned with RBQM

  • Technology solution consulting (EDC, data visualization, etc.)

  • PRO (Patient-Reported Outcome) selection

  • Participation in regulatory interactions

  • Statistical input on dose selection

  • Participation in internal or vendor meetings as needed

  • Interviewing potential new employees

Engagement Rates

I offer monthly retainer packages designed to give early-stage biotech teams senior-level support in biostatistics and data management—without the overhead of hiring costly staff full-time or relying on high-markup CROs. These packages are structured to provide consistent, hands-on expertise with the flexibility to scale as your needs evolve.​ Contact me to discuss.

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