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Site Management & Monitoring

CEERI supports clinical studies across a large number of clinical sites in central and eastern Europe as well as the Balkans. In order to facilitate multi-site studies for pharmaceutical companies that require large patient population coverage, CEERI provides a centralized process of managing and monitoring sites with robust IT infrastructure and is staffed by highly qualified individuals. This enables companies to handle several sites at the same time with no incremental resources or costs. 

CEERI Site Management Services:

  • Study Site Feasibility and Qualification - According to Protocol Requirements

  • On-site Investigational Team and Study Staff Training

  • Patient Recruitment

  • Archiving Trial Documentation and Quality Control


Our Clinical Research Coordinators and Monitors follow Sponsors' or our own Standards of Practice (SOP's). We are also able to use our own monitoring plans and procedures and GCP (Good Clinical Practice) online training.

 

CEERI Monitoring Services: ​

  • Pre-study Site Evaluation Visits

  • Investigator Assessments

  • Investigator Enrollment

  • Study Site Feasibility

  • Study Site Initiation Visits

  • Regulatory Document Preparation and Collection

  • Budget and Contract Negotiation

  • Staff Training

  • Documentation Maintenance and Updating

  • Study Development Monitoring

  • Study Site Close-out Visits

 

CEERI staff trained to:

  • Clarify protocol issues with the investigational team

  • Handle protocol amendments

  • Review source documents related to clinical study data

  • Report adverse events

  • Ensure patient safety and enrollment procedures

*CEERI’s services are conducted in accordance with ICH and GCP guidelines and local regulatory requirements.