Services

Biostatistics

The Biostatistics Department of GMCS provides comprehensive statistical and programming services specifically designed to meet the needs of your study.

Services

Our experienced biostatisticians and well-trained SAS programmers can provide a package of services including:

Statistical Service

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

SAS Programming Services

• Creation of standard and customized analysis datasets according to Clinical Data Interchange Standards Consortium (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

Therapeutic areas

- Stroke

- Hypertension

- Hyponatremia

- Chronic Heart Failure, CHF

- Coronary Artery Disease, CAD

- Pulmonary Arterial Hypertension

- Rheumatoid Arthritis

- Diabetes

- Hepatitis

Technical environment

- Statistical computing enviroment (SCE)

- Up-to-date SAS system, version 9.1.3

- Independent CVS server

- nQuery Advisor 6.1