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Strategic Consulting
Analysis/Programming
Data Management
Interim Analyses

Strategic Statistical Consulting

bulletsample size calculations
bulletstudy design for optimal clinical efficacies
bulletclinical trial simulations
bulletpreparation for FDA interactions/meetings (e.g. end of phase II, pre-NDA, etc.)

Statistical Analysis and Statistical Programming

bulletExpert SAS programming and other statistical packages
bulletFinal Study Report Summary Tables and Listing Generation
bulletStatistical Analysis of ECGs - Through QTc Prolongation Studies
bulletmanuscript ready statistical graphics

Interim Analysis for Data and Safety Monitoring Boards

bulletDesign and analysis of interim analysis using all group sequential methods
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Extensive experience in cardiology and rheumatology including regulatory review and approvals

Data Processing and Management

bulletCompletely validated data entry system with automated audit trials
bulletelectronically scanned CRF images provided 
bulletDouble-data entry with compare
bulletExtensive review of data by physican prior to release

 

 

 

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Last modified: February 04, 2005