Quality Management

Building in quality

As part of our Quality Management System Scope International’s quality assurance team works autonomously and independently to ensure impartial evaluation – internally for us and externally for you, by auditing according to ICH-GCP and other applicable requirements to meet regulatory standards. With our proactive approach, our quality management team identifies areas for continuous improvement and develops risk-based auditing strategies. Consequently, the implementation of standard operating procedures (SOPs) and realization of corrective and preventive actions (CAPAs) is supervised by the quality management team.

Training of our employees is supervised by our quality managers and ruled by internal training matrix to allocate skilled team members at all stages of the project. To provide the best quality, we assign every project a dedicated quality professional, mandate a quality plan for every study and monitor performance and quality outcomes of all involved parties.

For more information on how we can support your quality needs, contact us.

Quality throughout – Management is just as important as constructive co-operation.

Auditing services – Clinical Trials

  • Clinical Trial Protocol
  • Informed Consent Form (ICF)
  • Investigator sites
  • Clinical Database
  • Clinical Trial Report (CTR)
  • Trial Master File (TMF)
  • Third-party service providers
  • Case Report Form (CRF)
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