Experienced quality assurance professionals establish quality structures and streamlined approaches to reduce risk and reinforce operational innovation in the changing landscape of clinical quality and compliance.
Overview of Expertise
Global compliance management
Gap analysis investigation for companies or internal departments
Developmental oversight of Quality Management Systems (QMS)
Internal and external auditing and compliance strategy planning and guidance
Vendor and site auditing on behalf of sponsors (and internally as part of our own QMS)
Development of required policies / SOP preparation /review / approval
Development and implementation of change management programs
Development and implementation of change and/or training programs of all quality-related aspects and metrics
Oversight of the development and delivery of all quality-related training (including regulatory updates and current GCP training)
Clinical quality oversight on behalf of a company
Rapid assistance in managing quality issues that arise during the course of a study
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