Using Pharsight® Trial Simulator™

Protocol Design

The Trial Simulator supports realistic trial protocols, including parallel, n-by-n Latin square, and crossover designs with any number of treatment groups and periods. The study enrolls subjects from one or more study centers, each of which may draw subjects from a different sub-population with different covariate distributions. Subjects may be screened for trial inclusion based on covariate values and/or responses measured during an optional lead-in phase. Active-phase treatments and observations may include any number of doses and measurements, scheduled at specific times or using a recurring cycle of times, e.g., BID. Trial Simulator accomodates adaptive dosing schemes, and covariate or response based dose adjustments. A protocol report is available for printing, directly to a printer or to Microsoft Word®. It includes all protocol settings, a graphical timeline of the protocol, and a table of scheduled events.

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