Quality Assurance & Quality Control

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.