Quality Assurance: Investigation Trials & Postmarketed Projects Phase I-IV

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. Through the auditing process, Chiltern’s QA group strives to evaluate protection of subject rights and that study data has been generated, documented and reported in a reliable and verifiable manner. Audit reports are issued, and follow-up may include debriefing meetings and review of corrective/preventive actions, if needed. Chiltern QA auditors can also provide ongoing GCP support and advice to internal and external clients and consult on the assessment, maintenance and implementation of quality management systems.