At ancillarie, Quality Assurance (QA) services help our clients ensure the integrity of their clinical trials. Our QA team interacts directly with clients to understand the specific requirements for their project and ensure adherence to the client requirements and applicable regulations during each phase of the clinical trial process. Our experience and oversight means that our services comply with applicable regulatory requirements.
The QA team provides oversight of the Quality Management System (QMS) and as part of our commitment to continual improvement. We measure, assess and report quality data while seeking ways to continually improve performance and results. Key QA services include:
GCP consultancy services
Conducting GCP audits including audits of investigator sites and clinical databases.
Conducting systems/processes for Data Management, Statistical programming, Pharmacovigilance, computer systems etc.
Audit of clinical study documents
Management of clients’ QA GCP programs and CAPA programs.
Conducting root cause analysis and handling of for-cause situations.
Mock Inspection and Inspection Readiness training.