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Quality assurance

Resources

QMS Director
QA Officer

Description

ClinSearch’s QMS department is led by an expert with multi-year experience in pharmaceutical Quality Assurance. The department is centered around maintaining and continuously improving the Quality Manual and SOPs of ClinSearch to ensure high quality of service and client satisfaction, as well as the immediate correction of any process that might cause deviations from regulations or best practices.

The QMS Director is also closely involved in ensuring the continued training and education of each staff member per function and the update of training requirements in accordance with changing regulations and practices.
Although the QA department is primarily internal in focus, we provide external services to Sponsors who might benefit from an independent QA review of their processes, need support with their SOPs development, or would like to integrate audits into their study management.

Our solutions

TMF audits
CRF audits
Investigative site audits
GDPR & Data Privacy audits
SOP writing
CAPA management
Sub-contractor audits
Client audits

Standards & Guidelines

ISO 9001:2015

Day-to-day activity

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