Details
In the process of bringing a new drug to market, every day counts - especially during clinical development, when delays can add up to millions of dollars in added expenses and lost revenues. Pharsight Trial Simulator helps you to minimize risks and guide decision making by formalizing assumptions and quantifying uncertainties about your drug and upcoming trials.
Pharsight Trial Simulator balances ease-of-use with powerful patented technology (U.S. Application No. 7,043,415) for defining and testing interactive drug models, exploring and communicating study design attributes, and performing statistical and sensitivity analysis through graphical and statistical summaries. Trial Simulator models encapsulate existing scientific knowledge, to help your entire clinical development team communicate and test ideas, and plan relevant, effective trials for every phase of clinical testing. Pharsight Trial Simulator helps you to anticipate risks and preview the range of expected results before R&D dollars are committed to further development of a drug, and human subjects are exposed to experimental therapies.
Development team members of diverse disciplines use the Pharsight Trial Simulator to conduct a series of "what if" simulations comparing different trial, patient and drug activity scenarios. By varying simulation input parameters, your team can test the impact on trial results of changes in known information, assumptions about the drug and subjects, and variations in the trial design. Simulation addresses questions such as:
- How likely is trial success?
- What is the optimal treatment schedule for a particular indication?
- What is the expected range of responses across doses?
- How will a change in inclusion/exclusion criteria affect outcomes?
- How frequently should the response be measured?
- What is the impact of poor compliance or concomitant disease?
Benefits
- Build more informative trials
- Capture and communicate the knowns" and "unknowns" about your drug and target population
- Know the range of probable trial outcomes
- Compare trial designs across a range of assumptions
