Biostatistics

Our biostatistical staff members provide more than data analysis; they have in-depth knowledge of the methods for studying analgesic medications and the techniques that are used to analyze their results.

Lotus Clinical Research biostatisticians have years of experience processing and analyzing analgesic trial data. They have written numerous Statistical Analysis Plans (SAPs) and are distinctly familiar with the Division of Anesthesia, Analgesia, and Rheumatology Products’ (DAARPs’) position on analgesic data imputation, including MMRM, LOCF, BOCF, and WOCD, as well as more complex Rubin multiple imputation methods.

Our biostatisticians provide the following services:

• Protocol review to assure appropriate study design and randomization, capture of important and well-defined endpoints, and use of pertinent statistical models and methods of analysis
• CRF and diary review
• Analgesic SAP generation with emphasis on appropriate data imputation methods
• Sample and effect size estimation based on literature review Interim analysis and Independent Data Monitoring Committee (IDMC) creation, management, and support
• Statistical programming and modeling
• Table, listing, and figure generation
• Statistical support for study reports (e.g. CSR, manuscripts, investigator’s brochure [IB])
• Regulatory statistical consulting