CPS Cortex Ltd.

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

1. Submission of clinical trials for authorization, elaboration, adaption and preparation, of documents (protocol, summary, informed consent, and other patient documents) for submission to regulatory authorities and ethics committees.

2. Contract management.

3. CRF planning, and eCRF hosting with cooperation of a partner company whose profile also covers data management and statistics.

4. Organization and conducting of clinical trials 

•  Medical writing
•  Selection of clinical study sites
•  Feasibility studies
•  Organization of investigators' meetings
•  Opening and initiation of study sites
•  In-house monitoring
•  Regular monitoring of study sites
•  Adverse event reporting
•  Closing of study sites
•  Representation of the sponsor 
• Keeping contact with the local authorities 

5. Translation of documents used in clinical studies

•  Hungarian, English, German, Italian

Cortex staff is highly educated and have wide experience in a number of therapeutic areas. Please check our website for further information at www.cortexps.hu .