Study management services overview

TREAT-NMD’s infrastructure can support the trial planning and management process and we can work with other professional organisations to deliver your study. Companies can work with their existing CRO, choosing to buy into certain modules of the TREAT-NMD infrastructure such as the patient registries and trial site registry. However, there is also the option for a trial to be run exclusively through TREAT-NMD, using the Clinical Trials Centre (ZKS) in Freiburg, which is a highly experienced trial management facility which has extensive experience in neuromuscular clinical trials. Additionally within a very close cooperation with LabConsult®/ a commercial CRO all aspects of a clinical study can be comprehensively advised.

The Freiburg Clinical Trials Centre offers professional services in trial planning, conducting and supervising through to project management, monitoring and audits, as well as the evaluation of clinical trials according to effective regulations and the international quality standards of Good Clinical Practice (ICH-GCP). A team of experts from medical services, biometrics, data management, project management, study nurses, monitoring and quality management work closely together to deliver these services.

The team has experience in:

• Medicinal product studies before and after marketing authorisation
• Studies on non-medicinal therapies and medical devices
• Diagnostic studies
• Prognostic studies
• Epidemiological studies