Preparation of a study protocol, patient information/patient declaration of consent, and all other necessary documents
Approval:
Submission to the competent ethics commission for review of compliance with professional rules and to other competent authorities
Recruitment:
Selection and recruitment of the appropriate study centers and agreement of contracts with them
Implementation of the studies:
Technical integration and installation of eCRF in the study centers
Training and support
Monitoring:
Optional data monitoring subject to predefined quality standards
Data management:
Review of completeness and plausibility
Data analysis in consultation with the client
Final reports, publications:
Preparation of final reports, publications, abstracts, and posters on the basis of the analyses and submission of them to national and international congresses and scientific journals
