Investigator-initiated studies (IIT)

Studies initiated by investigators - for knowledge gain

Freedom of research is firmly anchored in Germany's Basic Law in accordance with Article 5. This also includes investigator-initiated trials (IITs).

Their objective is to gain knowledge in order to optimise diagnoses or therapies, for example.

With the increasing commercialisation of hospital operations, there is often no longer enough space to conduct these non-commercial clinical investigations until they are published in accordance with the applicable regulations (AMG, ICH-GCP, MDR, IVDR, MPDG) and requirements.

MEDIACC supports academically active medical colleagues so that they can focus on their core tasks and apply their specialist knowledge to study design and analysis. To ensure that high-quality data can be generated and published alongside clinical activities, our clients benefit from our many years of experience with regulations, applications, processes, project management, regulatory affairs, biomedical expertise, conducting studies and successfully compiling publications.

In the case of investigator-initiated studies of medical devices that have CE marking and are used within the scope of the intended purpose and no invasive or stressful procedures beyond those clinically necessary are used in the clinical study, §(4) MPDG applies, as it is a "scientific or other issue". Due to the explicit regulation of § 47 (3) MPDG, the study could then be carried out in Germany after consultation with the ethics committee under professional law and without the involvement of the authorities.

This work enables the completion of the delegated tasks and thus increases the reputation of the department in order to publicise results nationally or internationally in a short time.

We will be happy to consult you on all aspects of the clinical study, please contact us at an early stage.