Full scale of veterinary trials
Our dedicated team is specialized in conducting national and multinational studies according to international standards (VICH GL 9) for veterinary medicinal products in Europe.
- Study Design
- Simulation of different designs (including group sequential and adaptive designs)
- Sample Size calculations
- Randomization and blinding scheme selection
- Medical writing
- Development of Clinical Study Protocol
- Development of Essential Documentation
- Final Study Report
- Obtaining Regulatory Approvalv
- Regulatory strategy and planning
- Document preparation for study submission
- Site selection and study feasibility
- Confidentiality Agreement (CDA) development
- Feasibility Questionnaire (FQ) development
- Site selection with own pre-qualified database
- Feasibility Report writing
- Study start-up activities
- Clinical Trial Agreement execution with selected sites
- Training of Study Participants
- Compilation of Study Files and Patient Binders
- Conducting Site Initiation Visits (SIV)
- Clinical Monitoring and Project Management
- Developing plans and timelines for research projects
- Routine Monitoring Visits (RMV) of investigational sites
- Site recruitment support
- Site payment management
- Remote Monitoring
- Partial and full source data verification (Risk-Based Monitoring)
- Quality Assurance
- Study audit plan preparation
- Performing independent audits of investigational sites
- Pre-inspection preparation visit conduction
- Data Management and Biostatistics
- Paper CRF and eCRF design and planning
- Development of CRF completion guidelines
- Development of Data Management Plan
- Paper based or Electronic Data Capture
- Database development, validation, and maintenance
- Data edit check planning and management
- Query Management
- Writing the Statistical Analysis Plan (SAP)
- Creating statistical tables, data listing and figures for clinical study reports
- Statistical Analyses and Interpretation
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