- Clinical study design and powering
- Protocol generation
- Case Report Form generation
- Informed Consent documentation
- Institutional Review Board/Ethics Committee
- Site screening, selection, financial package development, and Clinical Trial Agreement generation and negotiation
- Study supplies coordination
- Site training and initiation
- Study management
- Study monitoring and close-out
- Medical monitoring
- GCP compliance
- Database generation and data entry including Electronic Data Capture (EDC) capability
- Query generation and resolution
- Biostatistical analysis
- Quality assurance
- Clinical study report generation
- Regulatory submission support
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