What service do we offer?

In cooperation with our CF-CTN and external providers, we offer the following services in detail relating to the supervision of trials:

Medicine

Provision of contacts for advisory services (clinical, pre-clinical) in all aspects of CF; side-effect/SAE management, expert clinical/pharmacological reports

Planning of trials

Provision of contacts to clinics, research scientists and study groups; selection and contacts to test and reference centres; development and planning of trials (including preparation of trial schedules); feasibility checking; financial planning; Orphan Drug applications; assumption of role of sponsor in accordance with Federal Drug Act (AMG) as case may be.

Project management

Coordination of interdisciplinary trials; preparation of contracts and cost accounting; insurance of trial patients as required; contacts to official authorities; ethics commission votes; investigator meetings; trial documentation; final trial reports, presentation of findings, lectures, publications

Monitoring

Preparation/monitoring of the process of clinical trials at trial site

Data management

Preparation of Case Report Forms (CRFs); preparation of data for biometric evaluation; compilation and upkeep of databases; data input; data queries

Biometrics/ statistics

Definition of target criteria; case rate planning; trial design; randomisation; interim analyses; consistency and plausibility checks; encoding and preparation of data for statistical analysis; preparation of evaluation schedule; statistical evaluation, including preparation of final statistical report