NWORTH Quality Management System
How can the NWORTH Quality Assurance team support your study?
The NWORTH Quality Assurance (QA) team provide specialist advice to trial teams and NWORTH staff, ensuring that every trial is conducted in compliance with Good Clinical Practice (GCP) and all relevant regulatory and ethical regulations, policies and guidelines. Our QA team can support trial teams with:
- Conducting study risk assessments
- Answering general QA queries throughout the trial鈥檚 lifetime
- CRF and database verification and validation
- Archiving of trial documentation
The QA team also provide overarching QA oversight to the NWORTH CTU. They are responsible for:
- Development and review of standard operating procedures (SOPs)
- Training NWORTH team members
- Conducting internal audits to provide assurance that NWORTH systems and processes are fit for purpose & identifying opportunities for improvement
- Identifying non-compliance with SOPs and regulations
- Resolution of non-conformance & implementing corrective actions
- Maintaining all quality records and documentation
- Preparing for inspections/audits by regulatory bodies