We have an internal Quality Assurance Team of seven professionals who ensure that clinical trials are conducted per protocol and within ICH/GCP Guidelines, including:
- QA services performed by former big pharma monitors
- Comprehensive SOPs and employee training records
- Strong foundation in ICH/GCP/CFR highlighted by seven FDA Audits with no 483s issued and over 80 client audits with no significant findings.
- Parallel reviews of protocol, CRF and on study procedures (randomization, dosing, etc.)
- On study, real time Quality Control of critical phases
- Significant company resources invested in Quality Assurance and Quality Control