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Glossary

eTMF/ TMF: electronic Trial Master File / Trial Master File

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Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.

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Clinical Research

Big enough to deliver and small enough to care HealthTech developers, including…
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e-Publishing

VCLS assists life science companies to streamline the entire submission process from…

Other glossary definitions

P

Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the…

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G

Genetically modified organism (GMO)

Genetically modified organism (GMO) means an organism, with the exception of human beings, in which…

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