ICON’s Early Clinical Quality and Compliance team provide quality assurance support through study risk assessments, study and process audits, CAPA management, and hosting external audits and inspections.
In addition, the Quality Assurance team provides standalone contracted PK and TK report audit services to support companies in their drug development process.
Our QA services encompass the following:
- Internal Auditing
Clinical laboratories (GCP, GLP)
Bioanalytical data and statistical tables audits
Bioanalytical sample and validation report audits
Computer system validation report review and approval
Pharmacokinetic (PK) and toxicokinetic (TK) reports audits
With QA personnel located at our clinics and laboratories in Europe and the US, the ICON Early Clinical QA team is flexible enough to provide an individual and personalised service for locally managed projects.