Kinexum helps clients in applying quality principles in both clinical practice (GCP’s)and manufacturing (cGMP’s). Our quality experts assist in auditing, compliance,remediation, regulatory strategy, and quality system design and improvement including:
· Gap Analysis
· Clinical QA Audits
· Clinical investigator site audits and regulatory inspection preparation
· 3rd party service provider (vendor) assessment and selection
· Standard Operating Procedure – Authoring, Training, and Review
· Project management, trial monitoring, QC of documents and Data management (CRF development, review of data management plans, edit checks)
· Temperature excursion review and analysis
Quality experts from Kinexum can be deployed on an adhoc basis, by project, or as an integrated quality team member.