Biometrics

Biometrics is the heart and soul of Amarex. The name “AMAR” means statistics in Farsi, and the “EX” stands for excellence. Our bio-statistics department provides full service statistical support for all clinical trials, Phase I through IV.

The Amarex biometrics department is well established, with a staff that is knowledgeable in all principles of statistical analyses for pharmaceutical/academia/regulatory agencies. They are experienced statisticians with broad therapeutic expertise and in-depth regulatory/scientific experience and have successfully participated in approval
of many NDAS, PMAs, 510Ks. They also have active involvement in many advisory committees, Data Monitoring Committees and other scientific/regulatory discussions.

Biometrics services range from statistical analyses to serving as consultants, DMC statisticians, and FDA Advisory presenters, to teaching client’s in-house staff. Our statisticians have considerable involvement in clinical development from protocol concept to conduct, presentation, and publication of individual trial results.

As part of Amarex parallel-processing, our statisticians routinely compile, validate, and analyze data from large-scale clinical trials.

Amarex Biometrics Services:

• Statistical Sections of Clinical Protocols
• Sample Size and Power Calculations
• Statistical Analysis Plans
• Table and Listings Templates
• Populated Data Listings and Summary Tables
• Patient Profiles
• Statistical Analyses
• Interim Analysis
• Post-hoc Analysis
• Exploratory Analysis
• Meta Analysis
• Data Presentations/Defense
• Independent Statistician for DSMC
• FDA Advisory Committee
• MCA Presentation
• Electronic Submissions