Clinical Operations Network
Amselstra├če 25
D-68307 Mannheim, Germany
(nearest airport is Frankfurt/Main)
Tel.: +49 (621) 789 7000
Fax: +49 (621) 789 7010

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Investigator Initiated Trials (IIT)

Investigator Initiated Trials (IITs) provide pharmaceutical companies with clinical data for further understanding of their drugs. IIT data can help provide additional knowledge regarding off-label usage to reach new patient populations or how the combination of registered drugs might improve treatment outcomes. In addition, IITs are an important aspect of medical research in academic institutions.

In an IIT the investigator at the academic institution is acting as sponsor and investigator. Therefore, the investigator in the role of the sponsor is responsible for planning initiating and conducting the IIT. As IITs must follow the same extensive administrative requirements and legal regulations that apply to sponsor driven clinical trials (e.g. pharmaceutical companies) special knowledge regarding regulatory affairs, safety and quality assurance is required. Also the necessary time has to be considered in addition to the daily business in the hospital.

CONET assists the researchers who are confronted with the growing complexity of regulatory obligations for an effective preparation and implementation of their IIT. We will support you in all aspects of regulatory affairs, clinical monitoring, study management and all other needs.

Please feel free to contact us anytime for more information on how we can support your IIT.

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