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Services: Biostatistics

Cato Research has highly qualified and experienced statisticians and programmers who create statistical plans, conduct analyses and assist in the preparation of reports. The statistical summary and data displays include data analyses, summaries, listings, and CRF tabulations that conform to the FDA or other regulatory agency guidelines for submissions. Cato Research statisticians also take into consideration the special guidelines created within each therapeutic division of the FDA and other regulatory agencies.

We are particularly proud of our guidelines for the format and content of a Final Study Report, more often referred to by the FDA as an Integrated Clinical and Statistical Report. This report provides a comprehensive overview of the trial and an integrated statistical analysis of the clinical trial data. A former FDA Medical Reviewer consulted with Cato Research during the creation of our Integrated Clinical and Statistical Report format. The format for the Integrated Clinical and Statistical Report includes, in addition to other features suggested by the consultant, in-stream tables, figures, and convenient summaries of data that may be used by the FDA in the preparation of FDA reviewer documents. Numerous sponsors and FDA representatives have complimented Cato Research on the high quality and clarity of presentation of the Integrated Clinical and Statistical Reports produced by our project teams.