Services

Biostatistics

GRS provides comprehensive statistical and programming services specifically designed to meet the needs of your study. With our strong clinical experience, our biostatistics team has the expertise needed to customize data programs and protocol design. GRS will prepare a Statistical Analysis Plan (SAP), create analysis datasets using SAS programs and, upon database lock, prepare the final analysis for your study, including a quality assurance review of all data displays prior to transfer.

Statistical Services

• Clinical protocol preparation
• Clinical trial design
• Sample size /statistical power determination
• Several analysis strategies (Interim, final, ISS, ISE, pooled analysis)
• Randomization schedule generation
• Development of statistical analysis plans (SAP) and analysis
• DSMB and CEC support
• Integrated clinical/statistical report writing
• Cardiac safety analysis consulting including QTc analysis
• CRF design and review
• Database setup and review
• Statistical consulting

SAS Programming Services

• Creation of standard and customized analysis datasets (according to CDISC* standard or sponsor's format)
• Development of tables, listings and figures (TLFs)
• Creation of pooled database for ISE and ISS
• Programming validation
• Preparation of electronic data submissions

*CDISC: Clinical Data Interchange Standards Consortium