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
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Inspection readiness
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Clinical laboratories (GCP, GLP)
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Bioanalytical data and statistical tables audits
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Bioanalytical sample and validation report audits
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Computer system validation report review and approval
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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.
In this section
In this section
- Decentralised Clinical Trial Solutions
- Real World Intelligence
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Cardiac Safety Monitoring
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Clinical & Scientific Operations
- Biostatistics
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Case studies
- Clinical Operations
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Clinical Supplies Management
- COVID-19
- Clinical data science
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Endpoint Adjudication Services
- Global Logistics
- Interactive Response Technology
- Investigator Payments
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Medical Affairs
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Medical Call Centre Services
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Medical Writing & Publishing
- Pharmacovigilance
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Project and Program Management
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Site Identification and Feasibility
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Consulting
- Early Clinical
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Laboratories
- Language Services
- Medical Imaging
- Site & Patient Solutions
- Strategic Solutions
- Symphony Health
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Technologies
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Decentralised Clinical Trial Solutions