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

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