EDC



News

AmberCRO has received appreciation for successful collaboration with the German companies ... [more]


AmberCRO Vice President and CEO/President will take part in EuroMedtech 2010... [more]


AmberCRO actively started to perform clinical studies with medical devices... [more]


AmberCRO Vice President and CEO/President had participated BIO Europe Spring 2010 ... [more]


AmberCRO has been awarder by the Latvian Governmental Institution (LIAA)  ... [more]

 
Our services
 

AmberCRO conducts all Clinical trial activities under GCP standards.  AmberCRO can provide all clinical trial activities for a Clinical trial.

 AmberCRO can perform Clinical trials Phase I-IV in Baltic States (Latvia, Lithuania and Estonia) and Multinational Clinical trials.

AmberCRO has reliable partners in America, Russia, Ukraine, Hungaria etc. 

  • Study Design, Protocol Development, Case report Form, Design and Preparation.

  • Selection process. Site and Investigator selection.

  • Regulatory Consultation. Preparation and submission of Regulatory documents (clinical trial application/ Notification).

  •  Interaction with the Investigator. AmberCRO has its own Data Base with experienced investigators (endocrinology, cardiology, inflammatory diseases, surgery, neurology, psychiatry, vascular surgery, gastroenterology, urology, oncology, dermatology, ophthalmology, (dentists, pediatricians), etc.

  • Organize Investigator meeting, qualify and train Investigators

  • ICH/GCP training (see ICH GCP for web_ENGDownload ICH GCP for web_ENG.ppt and ICH GCP for web_LATDownload ICH GCP for web_LAT.ppt)

  • Site Management and Monitoring Based on SOP's and study specific procedures.

    • Site Initiation

    • Monitoring visits

    • 100% SDV

    • Adverse Event report

    • Site Closure visits

 
 
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