BioTech/Drugs - N/A, N/A, N/A
Statistical consulting and statistical programming company with highly experiences statistician and statistical programmers.•Statistical Strategy for Drug Development •Phase I-IV Clinical Study Design •Adaptive Design •Two-Stage Clinical Study Designs •Power/Sample Size Calculations •Randomizations •Protocol Writing/Review •CRF Design/Review •Development of Statistical Analysis Plan •Interim Analyses & Reports (e.g. stopping rules, timing etc.) •Statistical Programming of Tables/Listings/Figures (TLF) •Quality Assurance and Validations of TLFs •Ad Hoc Analysis •Independent Review of Statistical Analysis •ISS/ISE (Integrated Safety Summary/Efficacy) •Data Safety Monitoring Support •Survival Analyses •NDA Submisson Support •CRO Evaluation and Supervision •Teach Statistics
Outlook
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