University Institutions

Investigator Initiated Trials / IITs

Since the 12th amendment of the German Drug Law (AMG) dated August 2004, the same requirements apply to for your drug research as used only to be applicable to the pharmaceutical industry (in particular see §§ 4/23, 41/1 AMG, EU GCP ordinance). This is a big challenge which you have to face. You as the sponsor of clinical trials have to act in a legally binding fashion. Thus, according to legal provisions, you are responsible for

ensuring the financing
the sufficient and qualified staffing
all organisational requirements

of your clinical trial.

Only the strict adherence to legal requirements ensures a sufficient "inspection security" from supervisory authorities that increasingly focus on Investigator Initiated Trials/IITs within the context of the inspection activities.

These "administrative issues" should not reduce your effectiveness as study centre.

In order to avoid this ECHOconsult offers you support in the development, correct planning and realization of self-initiated clinical research projects.

The service of ECHOconsult