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