Set-up of clinical programs and design of Clinical Development Plans
Design, organisation, conduct and monitoring of clinical studies, phase I–IV
Preparation of documents related to clinical studies:
CRFs, patient information, patient consent, monitoring documents, etc.
Preparation of submission dossiers to independent ethics committee (IECs)
Notification of clinical studies to health authorities, i.e. Swissmedic
Organisation and conduct of clinical questioning, an alternative to clinical studies
Medical writing:
Protocols, Clinical Study Reports, Investigator Brochures, etc.
Writing publications for national and international journals.
Quality Assurance
All those planned and systemic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded) and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
 
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