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