CRO Services

Geneticist's CRO Services provide comprehensive clinical trial services in Eastern Europe (I-IV phases). Our areas of expertise include oncology/hematology, psychiatry, autoimmune disorders, cardiovascular diseases, and sites/investigators identification.  

Project Management

  • developing and maintaining study plan and timelines
  • communicating study expectations to team members
  • provisioning study-specific training for CRAs
  • study budget preparation
  • preparing meetings with agendas and minutes
  • preparing enrollment notification and updates, site newsletters, study updates, protocol deviations, etc.

Clinical Trial Monitoring

  • On-site personnel training
  • On-site monitoring (pre-study, initiation, interim and close-out visits)
  • In-house site management, CRF review
  • Regulatory documents collection and review
  • Monitoring of regulatory status of studies on sites
  • Management of information collection from Investigational site
  • Monitoring reports completion
  • Query resolution
  • Participation in Investigators meetings

Safety Surveillance

  • SAE training of clinical personnel
  • Creation of study-specific SAE reporting Standard Operating Procedures
  • SAE reporting and Sponsor notifications (24 hours 7 days a week)
  • Preparation and submission of SAE reports to Regulatory Authorities, Investigators, and to local Ethics Committees
  • Generation of SAE narratives and follow-up reports, translation of medical records