Belgium - EN
- Home (Belgium)
- Knowledge Center
- Case Studies
- CluePoints: Quality Management System Development and Implementation
Case Study
CTG Develops and Implements Reliable QMS for CluePoints
CluePoints
CluePoints, the pioneers of risk-based Study Execution Solutions, offers sponsors and contract research organisations a better way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety and delay the approval of investigational products.
CHALLENGE
When CluePoints was established in 2012, they needed to develop and implement a Quality Management System (QMS) to ensure compliance with Good Clinical Practices
SOLUTION
CTG supported CluePoints in the development of their QMS by:
- Recruiting and training a Quality Assurance Coordinator
- Coaching the Quality Assurance Responsibles
- Developing tailor-made QMS deliverables (policies, procedures, work instructions, forms) such as, but not limited to: Computer System Validation, IT Infrastructure Qualification, Quality Risk Management, Data Protection
- Performing vendor audits
- Participating in customer audits
- Providing compliance-related support
Let’s discuss
How CTG can help you achieve your desired business outcomes through digital transformation.
Send us a short message by completing the contact form and we’ll respond as soon as possible, or call us directly.