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Our biostatisticians program endpoints from your raw datasets. Our SAS programming team starts from derived analysis datasets. Simultaneously taking these two different approaches gives us an extremely high level of confidence when we compare results in the end.
We encourage the use of CDISC formatting to make the approval process far more efficient and effective, and we are highly skilled in its use.
ClinOps’ Ph.D. and M.S. level biostatisticians and SAS programmers are highly skilled not only in every aspect of statistics, but also in determining study objectives, sample size calculations, appropriate timelines and statistical analysis plans that deliver optimal data for all of your clinical, regulatory and marketing needs.
Our extensive experience includes the following services for all phases of a study, across all therapeutic areas:
- Protocol Review & Development
- Study Design
- Sample Size and Power Calculation
- Randomization Schedules & Implementation
- Statistical CRF and Database Review
- Statistical Analysis Plan
- CDISC Study Data Tabulation Model (SDTM) Mapping & Conversion
- Analysis Dataset Programming and Documentation
- Tables, Listings and Figures Programming
- Tables, Listings and Figures Validation and Quality Control
- Interim Analysis
- Patient Profiles
- Physician Reports
- ISS/ISE Preparation
- Ad hoc Statistical Support
- DSMB/SMC/DMC Participation
- Statistical Representative at FDA Pre- and Post-Submission Meetings
Click here to download a pdf with more information on our Biostatistics services.
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