Our Statisticians have experience in the design and analysis of highly complex clinical trials. They are available to work with our clients in the study design stages, in interim analysis situations if needed and in the final statistical analysis and reporting stages of successfully completed studies.
Statistical services include:
Statistical Regulatory Support
- FDA preparation, consultation and meeting attendance
- NDA/CTD regulatory filings-Integrated Efficacy/Safety Summaries
- Electronic filings
Statistical Consulting
- Study design, sample size estimation, randomization
- Protocol development
- Clinical program development
Statistical Analysis
- Statistical Analysis Plans
- Table mock-ups
- Programming and analysis specifications
- SAS™ programming
- Analysis data sets preparation
- Report tables
Statistical Interpretation
- Interim analyses and reports
- Data Safety Monitoring Board reports
- Final statistical reports
State-of-the-Art Technology Platforms
We use Oracle™ Clinical database software, a validated clinical data management system, as well as SAS™ and S-Plus Analysis™
software. At Clinimetrics, we combine state-of-the-art technology with professional expertise.
- Oracle™ Clinical (Web enabled)
- Oracle™ Clinical TMS (Thesaurus Management System)
- Oracle™ Clinical AERS (Adverse Event Reporting System)
- SAS™
- MedDRA™, WHO Drug™
- InteractiveTrials™ Management System
- EDC (Electronic Data Capture)
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