For More Information - Please also view these partners:
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Strategic Statistical Consulting
| sample size calculations |
| study design for optimal clinical efficacies |
| clinical trial simulations |
| preparation for FDA interactions/meetings (e.g. end of phase II, pre-NDA,
etc.) |
Statistical Analysis and Statistical Programming
| Expert SAS programming and other statistical packages |
| Final Study Report Summary Tables and Listing Generation |
| Statistical Analysis of ECGs - Through QTc Prolongation Studies |
| manuscript ready statistical graphics |
Interim Analysis for Data and Safety Monitoring Boards
| Design 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
| Completely validated data entry system with automated audit trials |
| electronically scanned CRF images provided |
| Double-data entry with compare |
| Extensive review of data by physican prior to release |
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