Quality Management

Quality processes are embedded in the Pharma Clinical delivery model. Our dedicated QA Manager supports the project teams to ensure that established processes meet the needs of the project and that all the regulatory requirements are fulfilled to protocol specifications and in adherence with the applicable standards, such as:

  • International standards, namely ICH GCP
  • The Clinical Trial Directive 2001/20/EC,
  • GCP Directive 2005/28/EC
  • Code of Federal Regulations (FDA 21 CFR)
  • National guidelines / regulations and standards

Our quality management processes ensure:

  • Quality management planning
  • Compliance with SOPs
  • Audits and system reviews
  • Issue management review and escalation
  • CAPA procedures (Corrective Actions and Prevention Actions)

FDA audit:

    In 2008, the FDA audited one of the sites for which Pharma Clinical was responsible for its performance in Israel. The audit went very well without any major findings.