Kammerman Consulting
Regulatory biostatistics consultancy providing statistical review and regulatory strategy support for clinical development. Services focus on regulatory submissions and interactions, clinical trial design and analysis, and endpoint development with particular expertise in patient-reported outcomes (PROs) and guidance development informed by prior FDA/CDER experience.
Industries
Nr. of Employees
small (1-50)
Kammerman Consulting
Bethesda, Maryland, United States, North America
Services
Statistical review of regulatory documents, identification of likely regulator questions, drafting proposed responses, and preparation of teams for regulatory interactions.
Guidance on instrument selection, psychometric considerations, endpoint definition, analysis plans, and presentation of PRO and other COA-derived endpoints to regulatory agencies.
Design and statistical analysis services for clinical studies, including planning for labeling claims and balancing sponsor and regulator needs.
Statistical review of regulatory documents, identification of likely regulator questions, drafting proposed responses, and preparation of teams for regulatory interactions.
Guidance on instrument selection, psychometric considerations, endpoint definition, analysis plans, and presentation of PRO and other COA-derived endpoints to regulatory agencies.
Design and statistical analysis services for clinical studies, including planning for labeling claims and balancing sponsor and regulator needs.
Expertise Areas
- Regulatory statistics and regulatory submission support
- Clinical trial design and statistical analysis
- Patient-reported outcomes (PRO) and clinical outcome assessment development
- Adaptive and complex trial designs
Key Technologies
- Longitudinal modeling
- Adaptive trial design methods
- Time-to-event analysis
- Sample size estimation and interim analysis planning
News & Updates
Invited speaker at CDKL5 Forum Annual Meeting (How to design clinical studies for small populations)
Presentation on designing clinical studies for small populations, including regulatory evidence requirements, endpoint selection, instruments, and sample size considerations.
Named consultant to the External Technical Advisory Committee for Northwestern University Clinical Outcome Assessment Team to develop and validate clinical outcome assessments and core physical function outcome sets.
Attendance and written summary of the forum addressing statistical innovation, complex designs, real world data, master protocols, rare diseases, and estimands.
Appointment as Associate Editor of a scientific journal covering therapeutic innovation and regulatory science.
Invited speaker at CDKL5 Forum Annual Meeting (How to design clinical studies for small populations)
Presentation on designing clinical studies for small populations, including regulatory evidence requirements, endpoint selection, instruments, and sample size considerations.
Named consultant to the External Technical Advisory Committee for Northwestern University Clinical Outcome Assessment Team to develop and validate clinical outcome assessments and core physical function outcome sets.
Attendance and written summary of the forum addressing statistical innovation, complex designs, real world data, master protocols, rare diseases, and estimands.
Appointment as Associate Editor of a scientific journal covering therapeutic innovation and regulatory science.