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Regulatory: Submission of Clinical Trials for authorization, elaboration of documents for submission to authorities and ethics committees.

Hungary

CPS Cortex Contract Research Organization was founded in 2005 with the aim of becoming one of the most reliable partner of Hungarian and international pharmaceutical companies, CRO-s, universities, hospitals and other health institutions in the planning and realization of clinical trials from the beginning till the final report. Cortex has wide experience in various indications in clinical trials from phase I-IV, non-interventional studies, biosimilar studies, studies with medical devices, to registries. We operate in Hungary.

Services:

In case of phase I-IV. clinical trials, non-interventional studies, trials conducted with medical devices, registry studies, post authorization safety studies (PASS), post authorization efficacy studies(PAES) and biosimilar studies we offer our sponsors the following services:

-  Submission of clinical trials for authorization

-  Elaboration / adaption/ translationof documents for submission to competent authorities and ethics committees

  • Preparation of complete submission dossier depending onthe type of the study (including adaption to local requirements)
  • For sponsor’s files: preparation of complete submission dossier in English

We manage:

-  Clinical trials performed with investigational drugs:

-  National Institute for Quality- and Organizational Development in Healthcare and Medicines National Institute of Pharmacy (GYEMSZI OGYI)

-  Medical Research Council Ethics Committee for Clinical Pharmacology (ETT-KFEB)

-  Clinical trials performed with medical devices:

-  Authority for Medical Devices of the Office of Health Authorisation and Administrative Procedures (EEKH OTIG)

-  Ethics Committee for Science and Research of Medical Research Council (ETT-TUKEB)

-  Non interventional Clinical Studies, registries:

-  Ethics Committee for Science and Research of Medical Research Council (ETT-TUKEB)

Company
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CPS Cortex Ltd.

József nádor tér 5-6
H-1051 Budapest Hungary
Homepage: http://www.cortexps.hu