Geneticist's CRO Services Provide comprehensive Clinical Trials services in Eastern Europe (I-IV phases). The major area of our expertise includes: Oncology/Hematology, Psychiatry, Autoimmune disorders, Cardiovascular diseases, Sites/Investigators identification.  

Project Management

• Development and maintenance of study plan and timelines
• Communicating study expectations to team members
• Provision of study-specific training for CRAs
• Study budget preparation
• Preparation of meetings with agendas and minutes
• Preparation of 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