Services

My consulting services span the full biometrics lifecycle, from early‑stage planning to regulatory‑ready deliverables. Whether you need targeted support or end‑to‑end guidance, I provide clear, collaborative, and scientifically grounded expertise.

    • Protocol input and statistical strategy

    • Sample size and power calculations

    • Endpoint selection and justification

    • Randomization plans and IWRS set-up

    • SAP and TLF shell development

    • Statistical analysis for Phase I–IV studies

    • Real‑world evidence and observational study analysis

    • Interim analyses and DMC support

    • Interpretation and communication of results

    • CSR statistical contributions

    • Oversight of statistical, data management, and programming activities

    • Review of deliverables for quality, consistency, and regulatory alignment

    • Vendor performance monitoring and issue resolution

    • CRF design

    • Edit check specifications and data management plans

    • UAT and database review

    • Data cleaning strategy and oversight

    • Oversight of CDISC SDTM and ADaM dataset development

    • Review of define.xml and reviewer’s guides

    • TLF programming strategy and QC oversight

    • Process capability and performance analysis

    • Stability study design and evaluation

    • In vitro bioequivalence testing

    • Bench study design & analysis

    • Development of fit‑for‑purpose, risk‑based SOPs

    • Biometrics process mapping and optimization

    • Audit preparation and representation for statistics and data management

    • Support in building or expanding biometrics teams

    • Guidance on resourcing models (in‑house, FSP, outsourced, hybrid)

    • Training for statisticians, data managers, and cross‑functional partners