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Glossary

Safety concern

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An important identified risk, an important potential risk, or important missing information.

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Vigilance

From pre-market product safety to post-market surveillance, we provide integrated vigilance services…
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Clinical Safety Management

Multi-disciplinary approach to identify, assess and minimize the risks​ Clinical safety management is…

Other glossary definitions

S

Specification

A list of tests, references to analytical procedures, and appropriate acceptance criteria  

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C

Case Report Form (CRF)

Data collected in the frame of a clinical trial must be recorded in order to…

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