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Veeneman Clinical Consultancy can help you perform the following:
Submission of a clinical trial to the accredited Ethics Committee for central approval, to hospital boards for local approval, to the CCMO (competent authority for the Netherlands) for approval according to Dutch and international laws and regulations.
Completion of study related forms like the patient information, informed consent, contracts, ABR-form, patient cards, newsletters, etc, if necessary with translation to or from English.
Translation of (discharge)letters during the clinical trial for safety data.
Development of study files (ISF and TMF) with the necessary essential documents, both for investigator sites and for sponsors.
Completion of Case Report Forms (CRFs) in hospitals.
Development of checklists for patient information/informed consent sheets and for monitoring visits.
Any other support with regard to clinical trials. |
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