We specialize in sensory and consumer studies with clinical components and studies requiring IRB (US) approvals.
Purpose of GCP
- To protect study participants, subjects and panelists
- To ensure credible and accurate data
International service includes China, Great Britain, Germany, Switzerland.
Full-service covers
- Recommend study design following GCP requirements
- Provide regulatory documents
- Maintain investigator’s binder
- Collect and keep source data
- Drug/test sample accountability
- Staff training and qualification
- Protocol development
- Screener development
- Prepare Informed Consent Forms
- Prepare IRB required documentation and IRB package submission
- Study site selection, auditing, fielding
- Medical monitoring (MD on call or RN on site) and Adverse Event reporting
- Project management
- Statistical analysis
- Report writing