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Biostatistics

Based upon experience with several successful clinical trials, we have determined that collaboration with an experienced statistician during the early planning stages, rather than at the end of the trials, allows their expertise to influence the decision-making processes, promotes cost-effectiveness and adds an important measure of quality control.

AT THE PLANNING STAGE

In the beginning of any successful clinical trial, the statistician's input is key:

Design, analysis and interpretation of animal or pilot studies
Sample size estimation for clinical trials
Identification of appropriate measurement techniques
Selection of appropriate study design
Design of data entry forms
Initiate a dialog with the FDA statistician.

DURING THE STUDY

The statistician's expertise is needed during the study as a control measure in many areas:

Assure and monitor accurate data collection
Establish data base - oversee data entry and quality assurance
Provide interim results
Evaluate the effects of any changes in protocol.

AT THE END

The statistician's obligation is to perform appropriate statistical analyses and provide:

A concise report with objectives, hypotheses, descriptions of methods and variables
Discussion of results with clearly presented tables, charts and graphs
Explanations and conclusions, in a format comprehensible to both laymen and scientists
Written clinical reports for FDA submissions
Interaction with the FDA statistician during the review process.