IDDI, Biostatistical and eClinical Services for Clinical Trials

TRIAL DESIGN - RANDOMIZATION - DATA MANAGEMENT - BIOSTATISTICS
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Quality Assurance

An independent Quality Assurance team is dedicated to the coordination of implementation and maintenance IDDI’s Quality Management System (QMS).  It is at the forefront of the development and review of Standard Operating Procedures (SOPs) and ensures that study-related activities are performed in compliance with the Good Clinical Practice (GCP), protocol, contract, valid SOPs, applicable regulatory requirements and industry standards. 

The QA team is responsible for the following activities:

 

  • QMS auditing
    • Internal audits
    • Supplier audits
  • Sponsor audits and Regulatory Agency inspections
  • Nonconformities management
  • Continuous improvement processes
    • Corrective and Preventive Actions (CAPA) tracking system
    • Quality indicators monitoring
  • Development and periodic review of SOPs
  • QA SOP trainings and general GCP training
  • Computerized System Validation (CSV)
  • Information Security