image

 

 

 

Services >> Site Management


CEERI supports studies across large number of clinical sites in Central & Eastern European Region. In order to facilitate multi sites studies for sponsors that require large patients population coverage, CEERI provides a centralized process of managing and monitoring sites with robust IT infrastructure and staffed by highly qualified individuals; this enables sponsors to handle several sites at the same time with no incremental resource or costs.

CEERI site management services includes site feasibility and qualification according to protocol requirements; on-site training both to the investigational team and also to the study staff; patient recruitment services using internal call center; archiving trial documentation and quality control.

Our Clinical Research Coordinators and monitors may follow our or Sponsorís SOPs. We can also use our monitoring plans and procedures, and GCP online training. Our monitoring activities involve feasibility and study site initiation, study development monitoring and study close-out at the clinical site. Our staff are trained to clarify protocol issues with the investigational team; to handle protocol amendments; to review the source documents related to clinical study data and to report the advance events, and to ensure patient safety and enrollment procedures.

CEERIís services are conducted in accordance with ICH GCP guidelines and local regulatory requirements.


CEERIís clinical monitoring services include:

    • IInvestigators enrollment
    • Pre-study Site Evaluation and Investigator Assessments
    • Regulatory document preparation and collection
    • Budget and contract negotiation
    • Staff training Documentation maintenance and update
    • Site Initiation, Interim and
    • Close-Out Site Visits