BIOSTATISTICS

ACCURACY

Amarex was founded by a Biostatistican and biostatistics is one of the most fundamental parts of the services we offer for all phases of drug development and all therapeutic areas. We provide innovative clinical trial designs with the statisticians and statistical programmers who have years of industry experience and therapeutic knowledge.

Our Biostatistics team can provide full support to our clients by providing expert statistical design and identifying the best method of analysis for a particular protocol. These are the two fundamental elements in determining the efficient and accurate pathways to a positive trial result that will lead to product approval.

Using our PARALLEL PROCESSING method, a clinical study's statistical analysis can be completed within 24-48 hours after database lock. Our goal is to provide the best statistical support and strategy for our clients.

​Our services include:

  • Statistical Programming

  • Statistics Section of Protocol

  • End Point Selection Assistance

  • Adaptive Study Design Statistics

  • Statistical Analysis Plan Development

  • Randomization

  • Statistical Simulations of Clinical Trials

  • Statistical Analyses and Presentation to Independent Data Monitoring Committee

  • Analyses and Statistical Report Writing

  • Interim and Exploratory Analyses

  • Integrated Summaries of Safety and Efficacy (ISS / ISE)

  • Data Integration and Standardization (SDTM and ADaM)

  • Statistical Analyses Presentation and Defense before FDA

  • Statistical Consulting

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