Services
Trial Design and Statistical Support
At Databean, our statistical team ensures the use of appropriate and efficient methods of trial design and statistical analysis to support the development and submission of our clients' products according to U.S. standards, procedures and regulatory guidelines.
We are equipped to:
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Create statistical methodology section, including sample size calculation for study protocols
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Attend pre-IDE planning meetings with FDA
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Provide or work closely with clients' statistical programmers to ensure creation and validation of analysis data sets, statistical summary tables, listings, figures and statistical reports
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Perform inferential analyses, including documentation, to support decision-making and regulatory submissions, publications, and scientific presentations
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Interpret results in collaboration with our clients' scientific team
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Contribute to and review medical research reports in support of PMA/510K submissions
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Attend panel meetings in support of PMA applications
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