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
- Asset Development Consulting
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Blended Solutions
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Cardiac Safety Solutions
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Clinical & Scientific Operations
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Accelerated study start-up
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Biostatistics and programming
- Clinical Operations
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Data Monitoring Committee Services
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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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Accelerated study start-up
- Commercial Positioning
- Decentralised Clinical Trials
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Early Clinical
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Accelerated Pharmaceutical Solutions
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Bioanalytical Laboratories
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Biometrics
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Clinical Pharmacology
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Clinical Research Facilities
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Early Phase Oncology
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Early Phase Patient Studies
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Early Phase Obesity Trials
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Quality and Compliance
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TQT studies
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Quantitative Pharmacology and Pharmacometrics
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Volunteer Recruitment
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Accelerated Pharmaceutical Solutions
- Language Services
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Laboratories
- Medical Imaging
- Outcome Measures
- Real World Intelligence
- Regulatory Affairs
- Symphony Health data
- Site & Patient Solutions
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Strategic Solutions
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Technologies