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Glossary

Value Proposition

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The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where new value can be created and how the company can best capture that value. This understanding needs to be established early in the product’s development, optimally during phase II. 2. Create value for all stakeholders by understanding needs.

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E

Expedited Criteria

Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited…

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S

Substantial Amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that…

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