Quality Assurance (QA) and Quality Control (QC) systems and procedures must be implemented by every pharmaceutical company to ensure that the ICH GCP guidelines and applicable regulatory requirements are adhered to during all the stages of a study.
psn has significant experience auditing vendors, partners and clients. psn ‘s QA personnel can assist sponsors and investigators in improving the quality of study conduct and data collection through a range of audit services.
- In-house data audit: Comprehensive review of key documents in the Trial Master File according to ICH GCP and agreed SOPs.
- On-site audit: Audits of pivotal or supportive studies involving single or multiple investigator sites.
- Biometrics audit: Review of a specific rate of randomised tables and graphs on all key variables, control of the procedures for data management, query production and handling, data base alterations, statistical calculations etc.
- Clinical Report Audit: Audit of clinical reports against agreed SOPs and ICH GCP requirements.