Quality Assurance
Quality assurance (QA) is a systematic process for ensuring the quality of clinical trials and the data they produce. QualMedica Clinical Consulting will work with your team to identify gaps in your Quality Management System (QMS), then develop and implement essential components of a robust quality system. Our program mentors integrate into your team structure to provide consistent leadership and project oversight. This collaborative process creates trust and facilitates learning along the way. In the end, our goal is to develop a sense of ownership of the quality system that will continue to return benefits long into the future.
Areas of Expertise:
- Audit clinical trial sites to assess compliance with ICH-GCP and recommend improvements
- Develop Standard Operating Procedures (SOPs)
- Provide guidance on Corrective and Preventative Action (CAPA) planning
- Train investigators and coordinators on clinical trial procedures and regulatory compliance
- Assist in development of effective source document templates
- Training on the GCP E6 (R3) version