Internal quality management (QM) consists of:
- Regular internal GCP audits of clinical trials and processes
- Staff training in all aspects of GCP
- Writing and reviewing SOPs and work manuals
- Tracking staff training in all internal procedures
- Providing advice to staff in quality aspects of clinical trials
- Reviewing reports, plans, protocols and other documents written by staff for clients
External quality assurance (QA) consists of:
- Performing GCP QA audits for clients in the Asia-Pacific region
- Carrying out QA audits on prospective collaborations for Datapharm
- Providing advice to clients on QA, including writing standard operating procedures (SOPs)
- Training client staff in quality control (QC)
- Presenting at conferences or seminars on GCP, auditing
- Writing articles on GCP, auditing, QC procedures
Quality assurance is a requirement of Clinical Research. The regulations state that all sponsors and CROs must have adequate QA and QC systems in place. These consist of SOPs and other documents, as well as methods of ensuring that quality is built into every aspect of clinical trial work.
The role of GCP auditors in clinical research is becoming more important as the number and complexity of clinical studies increases. Together the auditor works with the sponsor, and trial site staff, to maximise the ethical standards of clinical trials and to minimise any risk to data integrity.
Auditors’ qualifications, experience and training are such that they are able to assess the overall integrity of a clinical trial with speed and expertise to help ensure the best outcome for all concerned.
Datapharm has provided auditing for over 50 clinical trials in many countries, helping sponsors bring their data up to the highest possible standards for presentation to regulatory authorities.