A WEALTH OF EXPERIENCE … Insightful Study Design and Analysis
With decades of industry experience, our biostatistics and programming team offers insightful analysis and accurate display of clinical data. Sponsors benefit from PROMETRIKA’s wealth of experience in study design, protocol development, statistical analysis plan preparation, analyses for individual clinical study reports, and preparation of integrated safety and efficacy sections of NDAs and other regulatory submissions. We have extensive experience in working with FDA statisticians and other reviewers on drug development planning, clinical study design, and statistical analysis issues.
Our programming team has conducted numerous projects producing CDISC SDTM and ADaM submission-ready datasets and the associated documentation.
PROMETRIKA’s expertise in biostatistics extends beyond that of traditional CRO services to the specialized areas of adaptive design and clinical trial simulations, meta-analyses, PK/PD analyses, analysis of stability data for drug expiration dating, and exploratory analyses in support of publications and industry congresses.
Our team provides the support necessary for the successful management of operations of an Independent Data Monitoring Committee (IDMC), including participation of PhD statisticians as voting or non-voting members.
Our commitment to quality and adherence to regulatory requirements necessitates rigorous validation of all statistical output.
- Study Design & Protocol Development
- Sample Size Estimation & Randomization
- Statistical Analysis Plan Preparation
- SAS® Programming
- Interim Analyses
- Statistical Writing for CSRs
- ISS, ISE and Statistical Sections of NDAs / EU Submissions
- Meta Analyses
- IVRS Validation
- IDMC Support
- SDTM Conversion Programming & Validation
- Adaptive Clinical Trial Design & Analyses
- PK/PD Analyses
PROMETRIKA’s Biostatistics Team — A Snapshot
- PhD and Masters level statisticians average 15 years of industry experience in all phases of clinical development
- SAS® programmers average 12 years of industry experience