A clinical study designed & executed to get statistically significant evidence of efficacy and safety in order to obtain its marketing approval by regulatory authorities. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
Glossary
Pivotal Clinical Trial
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Glossary
The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.
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