We
offer the following services for the planning and implementation of your clinical trials (medicinal products and medical devices) especially for Germany and Austria:
Consultation in the selection of the study design
Statistical aspects in planning studies, sample size calculation
Randomization
Preparation of the study protocol
Design of CRFs
Submission to the Ethics Committees
Submission to the Competent Authorities
Site selection and contract design
Import notification / import authorization
Monitoring
Project management, i.e. only one contact person for the sponsor
Assistance in documentation and logistics tasks at the study centre
Data management
Biometrical evaluation of data
Coding of Adverse Events using MedDRA terminology
Writing of Study Reports according to ICH-GCP guidelines
Composing a script for publication
From the favorable geographic location of our offices (Vienna and Bad Hall) several advantages arise, e.g. short travel distances, more comprehensive support of the study centers and thus lower costs.
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