elements™ is a fully validated, easily mastered design and analysis toolkit for clinical pharmacology trials and bioequivalence studies. With unmatched efficiency and accuracy, elements™ generates trial designs and analyses in compliance with internal and regulatory guidelines.

elements™ features a comprehensive array of utilities allowing users to rapidly investigate and plot sample size versus power levels or any other design parameter, compare two or more designs, and analyze trial data with a choice of numerous parametric and non-parametric tests.

Cytel's elements™:

• is powered by Cytel's powerful statistical algorithms for very fast, reliable results
• features an especially intuitive interface makes elements easy even for first-time users
• streamlines the design and analysis of clinical pharmacology trials and bioequivalence trials process
• was developed specifically for clinical pharmacologists and biostatisticians in the biotech, pharmaceutical, and generics industries
• is applicable to any therapeutic area

What Can It Do?

elements™ incorporates essential design and analysis tools for the most common clinical pharmacology studies. Users can quickly explore and determine viable trial design parameters including:

• Computation of minimum sample size required to achieve desired power level
• Required sample sizes across a variety of power levels
• Comparison of multiple designs on one screen
• Automatic generation of regulator-required review and approval documentation

Who Is Elements™ For?

Statisticians and clinical pharmacologists in the pharmaceutical, biotech, and generics industry, as well as trial planners at clinical research hospitals and academia.

Why Is It Important?

Cytel's elements™ speeds routine clinical trial design tasks allowing users to quickly and more thoroughly consider alternative design approaches.

With its built-in library of charts and graphics, elements™ helps convey important design concepts to the study team, facilitating better understanding of the design's intentions and potential options

Key Benefits

• Quickly create, compare, and save multiple clinical trial designs
• Explore and analyze data using industry-standard statistical tests and models
• Compare designs and analyses through easily created tables
• Convey important design information clearly with meaningful graphs and charts
• "Import from" and "export to" common data formats: txt, csv, xls, xml, SAS, and more
• Speed production of regulatory documentation

Key Features

• Equivalence and bioequivalence trials, typically used for determining if two drug formulations are absorbed, metabolized, and eliminated by the body in approximately the same amount over approximately the same period
• Superiority hypotheses, useful in verifying whether novel treatments provide better pharmacodynamic results than standard medications or placebos
• Non-inferiority hypotheses, commonly posited to confirm that a new therapy is as effective if not more than existing regimens
• Crossover designs, where each subject receives a sequence of treatment regimens are often used to reduce between-subject variability and reduce sample size
• Parallel studies, where each subject receives a single treatment regimen are standard for comparing clinical outcomes
• Paired-sample studies, in which all subjects receive the same sequence of treatment regimens
• Generate basic statistical analyses including t-tests, ANOVA, and correlations
• Plot categorical and continuous data with bar charts, pie charts, scatter plots, bubble, density, and other commonly used statistical plots for data visualizations
• Analyze frequency distribution with cumulative, histogram, stem-and-leaf, and step function plots
• Visually explore cross-over data using histograms, subject profile, treatment by period, and convex hull plots

Developed by Leading Experts

Rigorously validated and tested in accordance with FDA and CPMP guidelines, elements™ is developed by Cytel's team of experts in biostatistics and algorithm design, in consultation with leading clinical trial designers from the top 20 pharmaceutical and biotechnology companies.