Study support

Project management

Planning/preparation:

• conception, study protocol according to the Good Clinical Practice guideline
• support of grant applications
• budget planning, contract design
• drawing up patient information and informed consent forms
• approval procedure
• study logistics
• registration of studies

Conduct:

• central randomization
• coordination
• study documentation  (starting and maintenance of the Trial Master File and starting of the Investigator Site File)

Closing:

• support in writing final reports and storage of files

Clinical Monitoring

• development of the monitoring manual
• quality surveillance at the study site

Biometry/Study methodology

• study design, sample size and analysis planning
• biometric monitoring
• analysis and biometric report
• support in writing the publication

Data management/Documentation/IT

• development of electronic Case Report Forms (eCRF)
• data management plan
• data capture, plausibility checks and query management
• IT-supported  randomization
• EDC-system OpenClinica
• registration and pseudonymization of study participants
• survey systems