Quality Assurance Service: Investigation Trials & Postmarketed Projects Phase I-IV
Source: Chiltern
The function of Chiltern's independent QA auditing group is to assess, for investigational trials or postmarketed projects (Phases I-IV), the state of compliance with ICH-GCP and/or applicable regulatory requirements, Standard Operating Procedures (SOPs), the study protocol and/or project plans.
Chiltern’s QA group can offer full service auditing capabilities for any size project, whether national or international. Chiltern’s QA group is independent from the project teams and the following audits can be contracted as part of a full service project or individually as a standalone service.
- Protocol Audit
- Case Report Form (CRF)/eCRF Audit
- Patient Information Sheet/Informed Consent Form (PIS/ICF) Audit
- Investigator Site Audit
- Trial Master File (TMF) Audit
- Data Management Audit
- Statistics Audit
- Clinical Study Report (CSR) Audit
- Pharmacovigilance Audit
- Central Laboratory Audit
- Vendor/Supplier Audits
- System Audits
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