Quality Assurance

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