Many stakeholders in the healthcare industry are demanding more data and information on the effects of marketed drugs in the real world. Thus non-interventional and observational trials become incerasingly important to suppyl information on drug use after its market approval.
For conducting NIS, we collaborate with our key opinion leaders (KOLs) to expedite the set-up process and gain investigator awareness. We provide consultation with our know-how to assure the appropriate selection of design, the quality of planning, implementation, evaluation and reporting of the trial.
We prepare all study documents including observational plan, informed consent, eCRF, and site contracts. Furthermore we offer training of the participating sites at the start of the NIS and intensive support throughout the project by our trained monitoring team. Depending on your individual preferences and needs, we take over particular aspects or the entire process of your study – from registration to final evaluation.