Quality

Quality

SmartCRO has a highly-developed internal Quality Assurance program conducted in compliance with global Standard Operating Procedures (SOPs) to ensure compliance with  ICH GCP, ISO and Regulatory requirements and the integrity of the data we generate. 

We audit our vendors to ensure that they meet the standards that we set for delivery of their services. We also develop, maintain and execute QA audit plans for our investigator sites and clinical operations and as well provide support to our clients on an operational or strategic level.
  • Audit services (sites, sponsors, systems and technology).
  • SOP writing
  • General Data Protection Regulation (GDPR).
  • Risk-based approaches.
  • QMS setup and maintenance.
  • Strategic quality consultancy.
  • Conducting audits of the Quality Assurance System, reviewing existing documentation and proposing corrective and preventive actions (CAPAS)
  • ICH-GCP, ISO and Good Documentation Practices.
  • Inspection preparation.
SmartCRO requires  its staff to be appropriately trained. For that our staff is required to complete general services training such as Good Clinical Practices, Clinical Trial Management and Development and Good Documentation Practices. The reason for these requirements is to ensure we provide  really high-quality work and study management.
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