We take over preparation and submission (clinical trial application, CTA) to higher federal authorities (BfArM & PEI) and ethic committees. Therefore, we prepare the relevant documents, e.g. CTA, module-2, benefit and risk assessment, informed consent. This also includes collection and quality check of site documents as well as packing and shipment of documents.
By request we take over notification of regulatory authorities about the trial or investigators and process statements. During the clinical trial we care for preparation and realization of amendments as well as additional submissions of investigators and sites.
