Development and implementation of clinical quality assurance programs and procedures.
Services we offer
Preparation and/or execution of Clinical Quality Assurance Plans
Collaboration with colleagues in clinical development and operations, regulatory affairs, research and other relevant functional areas to jointly identify areas for quality improvement and propose specific quality improvement measures including monitoring Clinical QA effectiveness checks for process improvement
Appropriate documentation, reporting and closure of clinical compliance issues
QA Audit activities (clinical investigator sites and internal clinical systems and processes, audits of preclinical facilities, studies and activities, to verify adherence to Good Clinical Practice)
Investigational Product (IP) release and expiration dating issuing process
Preparation and follow up of Regulatory Authorities inspections
Identification and minimalization of compliance risks
Management of the Clinical CAPA program and Clinical Quality metrics
QA Compliance support to the Clinical Data Management program
