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About CLSI



StatisPro sets the industry standard for method evaluation that meets quality and regulatory compliance demands.

Produce reports on analytical and diagnostic accuracy, comparability, precision, linearity, limits of detection and quantitation, and reference intervals based on the most up-to-date CLSI standards.

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We’ll walk you through the process of selecting, entering, and analyzing study data in StatisPro.

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What’s New in Version 3.0?

statispro ep12

Implements CLSI document EP09-A3.

Includes information from EP09-A3 on Deming regression, Passing-Bablok regression, and Bias plots.


Includes information from CLSI document EP17-A2.

Improves study design to match new guidelines and includes limit of detection and limit of quantitation estimation from the precision profile approach.

statispro study template

Study templates let you easily create new studies based on similar previous studies.

Easily repeat those studies with the performance goals already captured.

PLUS: Complimentary access to all CLSI documents implemented by StatisPro—a $500 value!

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Access all the features with no commitment for 1 month.

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See StatisPro in Action


Introductory Webinars

Learn how to use StatisPro to create new studies, set performance goals, and more at this free webinar.

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Featured Case Study

“Using StatisPro to Verify or Transfer a Reference Interval”

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StatisPro is an excellent method evaluation tool. It is easy to use, yet it is packed with powerful features like outlier detection and flexibility in setting up studies. It has many sources of help available to new users, and it follows the CLSI guidelines. In the past year, we have evaluated more than 50 new or modified laboratory methods, and I cannot imagine completing the necessary validation and verification reports if it wasn’t for StatisPro.

– Jack Maggiore, Assistant Director, Chemistry Laboratory and R&D Doctor’s Data, Inc., St. Charles, Illinois, USA


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Learn all the ways that StatisPro helps you confidently meet quality and regulatory compliance demands.

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