MDSTAT Consulting
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Contact
3 rue gabillot
69003 lyon
France
Presidente
About us
MDSTAT Consulting is a consulting firm specializing in biostatistics, clinical trial methodology, and clinical development strategy. The company supports biotech and pharmaceutical companies in the design, analysis, and interpretation of their clinical development programs, with particular expertise in rare diseases, small patient populations, and regulatory interactions with the FDA and EMA.
Founded by a biostatistician with over 20 years of experience in the pharmaceutical industry, MDSTAT primarily supports projects requiring senior-level, independent expertise.
Business offer
MDSTAT Consulting provides flexible, senior-level support in statistical strategy and methodology, including Phase II and III clinical trial design, endpoint and estimand selection, sample size calculations and simulations, methods for small populations and rare diseases, statistical analysis strategies, protocol and Statistical Analysis Plan (SAP) review, statistical oversight of CROs, preparation for FDA/EMA interactions and support for regulatory submissions, as well as biostatistics training.
Engagements can range from one-off assignments, such as independent reviews or expert opinions, to more regular and ongoing support throughout a clinical development program.
Activities
- Consulting
- Other
- Clinical trials
- Phase II
- Phase III
- Phase IV
- Clinical biomarkers
- Predictive biomarkers
- Treatment efficacy
- Population stratification
- Risk/benefit profile
- Disease progression / follow-up
- Safety
- PK/PD features
- Surrogate markers
- Disease progression monitoring
- Regulatory filing
- Regulatory Filing
- Clinical trials
- Phase II (human challenge trials)
- Phase III (large population pending pathogen prevalence)
