Services provide comprehensive clinical trial services in Eastern Europe (I-IV phases)
We support therapeutic antibody development through cross—reactivity testing in human tissue and other species (GLP & non—GLP). Regulatory work is carried out using the FDA, EMEA, and MAFF panels of normal tissues.
Our experience means we can also support immunotoxicity lymphocyte sub—group analysis, cell proliferation studies, and diagnostic research services, as well as target validation and clinical biomarker assays.
- Tissue samples or biopsies
- Blood and bio—fluids
- FFPE samples
Ukraine Association of Biobank 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.
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
Participation in Investigators meetings
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