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Statistical Analysis and Reporting
Data Management
Database Design and Data Capture
Device Clinical Trials
Statistical Analysis
Ph.D. level statisticians and highly skilled programmers are knowledgeable on how to understand and interpret data correctly and employ statistical methodologies and data analysis techniques to analyze data and test study objectives.
Statistical tasks include:
- Creation of Statistical Analysis Plan as per study protocol
- Subject Randomization
- Design layout mocks for Tables, Listings and Graphs to support the data analysis per protocol
- Use appropriate Statistical models to test study objectives
- Exploratory, Interim, and Final Analyses
- Generation of Tables, Listings and Graphs (TLGs) in PDF format
- Creation of statistical report
- Export of data and data definition documents for FDA submission
SAS Programming
SAS is the popular and preferred statistical software application in both the pharmaceutical and medical device industries. SAS is a powerful tool for data analysis and is used to generate tables, listings, graphs (TLG) and other desired analyses in support of submissions to FDA or internal explorative objectives. FDA also uses SAS.
Our highly skilled, experienced, and efficient programmers deliver quality output (TLGs) for safety and efficacy analysis. We employ independent validation method where outputs generated by first programmer (Derived datasets, TLGs) are independently validated by a second programmer to assure quality of the results.