Accudata Solutions
Consulting firm providing biostatistics and study-design services to small- and mid-sized pharmaceutical, medical device, diagnostic, and biotech companies. Core offerings include clinical trial and protocol design, biostatistical analysis and reporting, pre-clinical/non-clinical experimental design, regulatory submission support, and data quality/management oversight. Principal consultant has over 25 years of experience and participation in multiple regulatory submissions.
Industries
Nr. of Employees
small (1-50)
Accudata Solutions
Lafayette, California, United States, North America
Services
Consulting on study design, endpoint selection, sample size estimation, and advanced design strategies to support regulatory submissions.
Statistical planning, randomization scheme generation, data checks, simulations, and production of TLFs for clinical study reporting.
Design and analysis support for animal studies, toxicology, QA/QC, assay validation, and methods transfer/comparability.
Design and analysis for verification/validation, reproducibility, diagnostic performance, methods comparison, and calibration to reference standards.
Consulting on study design, endpoint selection, sample size estimation, and advanced design strategies to support regulatory submissions.
Statistical planning, randomization scheme generation, data checks, simulations, and production of TLFs for clinical study reporting.
Design and analysis support for animal studies, toxicology, QA/QC, assay validation, and methods transfer/comparability.
Design and analysis for verification/validation, reproducibility, diagnostic performance, methods comparison, and calibration to reference standards.
Expertise Areas
- Clinical trial management and protocol development
- Biostatistics and statistical consulting
- Pre-clinical/non-clinical experimental design
- Medical device and diagnostic performance evaluation
Key Technologies
- Group sequential and adaptive trial designs
- Randomization algorithms and schemes
- CRF/eCRF design and edit-check frameworks
- Statistical simulations and bootstrapping
News & Updates
White paper describing common statistical and operational planning mistakes in clinical trials and recommendations to avoid them.
Article/PDF describing a randomized, double-blind pilot study and related statistical considerations.
Study examining predictors of ammonia exposure and hyperammonemic crises in patients with urea cycle disorders.
Reported involvement in 10 regulatory submissions, including leadership roles in multiple PMA submissions and contributions to NDA and 510(k) approvals.
White paper describing common statistical and operational planning mistakes in clinical trials and recommendations to avoid them.
Article/PDF describing a randomized, double-blind pilot study and related statistical considerations.
Study examining predictors of ammonia exposure and hyperammonemic crises in patients with urea cycle disorders.
Reported involvement in 10 regulatory submissions, including leadership roles in multiple PMA submissions and contributions to NDA and 510(k) approvals.