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Glossary

Serious Adverse Device Effect (SADE)

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Adverse Device Effect that has resulted in any of the consequences characteristic of a Serious Adverse Event.

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Clinical Investigations for Medical Devices​ and Digital Healthcare Products​

Your CRO partner for every step of your clinical investigation Clinical investigations…
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Vigilance

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

Other glossary definitions

R

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…

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A

Applicant for Clinical Trial Applications (CTA)

An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees. Applicant…

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