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    All services are provided according to applicable standards in clinical research industry:

    GENERAL

     

    • Nuremberg Code  

    • The Declaration of Helsinki 

    • The Belmont Repot 

     

    FDA

     

    • FDA Federal Regulations on GCP and Clinical Trials 

    • FDA Federal Regulation on Medical Devices  

     

    ICH

     

    • ICH Guideline on Good Clinical Practice (GCP) [E6] 

    • ICH Efficacy Guidelines  

    • ICH Safety Guidelines 

    • ICH Quality Guidelines 

    • ICH Good Manufacturing Practice Guideline (GMP) [Q7] 

    • ICH Multidisciplinary Guidelines 

     

    ISRAEL

     

    • Israeli MoH Guideline on Human Clinical Trials (2014) 

    • Israeli MoH Guideline on Adverse Events and New Safety Information Reporting 

     

    MEDDEV

     

    • MEDDEV Guidelines on Clinical Investigations of Medical Devices 

    • MEDDEV Guidelines on Clinical Evaluation of Medical Devices 

    • MEDDEV Guideline on Classification of Medical Devices 

    • MEDDEV Guideline on Post Market Clinical Follow Up Studies 

    • MEDDEV Guideline on the Medical Device Vigilance System 

     

     

     

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