Medical writing

 

 

 

CLINICAL STUDIES

 

Study protocol, patient information, study report, patient narratives, investigator´s brochure

 

• Indications: oncology, pain, myocardial ischemia, heavy menstrual bleeding

 

• Phases: I/II, II, IV

 

• Study type: interventional, observational (also with medical device), proof of concept, method validation

 

 

SUBMISSION DOSSIERS and REGULATORY DOCUMENTS

 

• CTD non-clinical and clinical overview and summary

 

• Product information (Summary of Product Characteristics, Company Core Data Sheet)

 

 

MEDICAL DEVICES

 

Clinical evaluation, investigational plan/study protocol, patient information leaflet; study submission documents for EC approval; (S)AE reporting, query management

 

• Indications/devices: colon systems, colon catheters; endovenous embolization; colorectal cancer resection, heart arrhythmias, defibrillator.

 

 Quality and Competence with Care

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