We offer a wide range of statistical services ranging from consultation on clinical study design, sample size calculations, pharmacokinetics, statistical analysis and data interpretation.
Statistical Services
Versagenics provides a wide range of statistical services for our clients ranging from consulting to analysis and interpretation.
Consulting
Our expert statistical staff can provide assistance with various statistical planning and analytic activities including:
- study design;
- sample size calculations;
- endpoint selection;
- independent review of case report form (CRF)design;
- independent review of study design, sample size determination, endpoint selection and review of results;
- participation on data safety monitoring boards(DSMB).
In addition, we are able to provide à la carte services including standalone statistical analysis, interpretation and compilation of integrated summaries for safety/efficacy.
Statistical Analysis Plans
We provide statistical analysis plans geared towards satisfying ICH GCP E6 guideline requirements for inclusion in the clinical study report.
Each plan prospectively outlines the types of analyses and the presentation of data that will form the basis for conclusions based on the study objectives outlined in the protocol.
In addition, the plan explains in detail how the data will be handled and analyzed, adhering to commonly accepted standards and practices in the pharmaceutical industry including draft table, listing and figure shell specifications for your review.
Statistical Reporting
We use SAS as our primary software application but have experience with many analysis-specific software programs including but not limited to: nQuery Advisor, EquivTest/PK, and Patient Profiles.
We work interactively with you and build an understanding of both the questions being asked as well as the types of data needed for the analyses.
We draw on a wide range of statistical techniques to accomplish our goals. Once the analyses are complete, we provide you with a formal interpretation of the analysis results ready for incorporation into the clinical study report.
The goal at Versagenics is to ensure that you have a comprehensive understanding of the final analysis package.
Pharmacokinetics
We have extensive experience with non-compartmental and compartmental pharmacokinetic modeling.
