Wizard provides biostatistic services, statistical analyses and programming to all phases of drug development in a wide range of therapeutic areas especially for clinical development plans, study design, statistical analyses, and regulatory support.All of our statisticians and statistical programmers receive ongoing, intensive training that incorporates Industry information such as 21 CFR Part 11, GCP and ICH standards such as ICH E9, Statistical Principles for Clinical Trials, SAS software programming skills and Statistical methodology
Wizard’s data managers and biostatisticians, in collaboration with the statistical programmers, offer comprehensive services including.
- Input to Study Design (including adaptive designs) and sample size calculation
- Statistical Analysis Plan (SAP),mock tables and LoT
- Guidance to programmers and review of TLGs (tables, listings, graphs)
- Statistical report and input to CSR
- Response to requests and queries from regulators
- Pharmacometric and Pharmacodynamic analysis and modeling
- Interim analysis and support to data and safety monitoring boards (DSMBs)
- Exploratory analyses for publications, abstracts, and marketing, including Meta Analysis
- Pre-Clinical Studies, PK/PD Analysis
- Data Mining, Cost Effectiveness & Finance and Outcome Research.
- Inputs into statistical analysis plan and mock tables
- Write programming plan, specifications, rulebook using CDISC (SDTM/ADaM)/sponsor specific standards
- Develop programs to perform required safety and efficacy analysis
- Validation and parallel programming
- Blinded data review
- Develop macros when possible, especially for safety analysis, using SDLC
- Develop programs to convert raw datasets to CDISC SDTM standards and mapping data across different standards
- Support the regulatory submissions by creating SAS xpt files
