You can train most statisticians to perform the complex data imputation methods required for analgesic clinical trials; however, they cannot offer value beyond what you teach. The Lotus statistical team has years of experience processing and analyzing analgesic trial data. They have written numerous SAP’s and are distinctly familiar with DAARP’s position on analgesic imputation (including MMRM, LOCF, BOCF, and WOCF).
- Regulatory Statistical Consulting
- Analgesic SAP Generation with Emphasis on Appropriate Imputation Methods
- Sample and Effect Size Estimation Based on Literature Review
- Interim Analysis and IDMC Creation/Management/Support
- Statistical Programming and Modeling
- Table, Listing and Figure Generation
- Statistical Support for Study Reports (CSR, Manuscripts, IB)