Quality Assurance

  • Audits of investigational sites to inspect activity, GCP and protocol compliance, study files, source documentation and information, specific issues (‘for cause audits’)
  • Audits of monitoring process to inspect compliance, knowledge of protocol and procedures, interaction with sites, skills and competencies
  • Audits of regulatory submission documentation for correctness and completeness
  • Audits of document flow and management in-house (trial master file), at vendor (vendor specific shadow files) and on-site (investigator binders)
  • Audits of external vendors to inspect certificates, accreditations, GXP and protocol compliance, quality and SOP system
  • Preparation of investigational sites for upcoming inspections by competent authorities (e.g. FDA, EMEA, CA, EC,…)
  • Write and implement SOPs complying with GCP standards, ICH and FDA