Specialised Service Providers/Supplier/Vendors Audits

• We can perform Software Supplier and Service Provider Qualification Audits to support organisations to make their best choice for their regulated activities. E.g. for:
  
  
  • Electronic Case Report Forms (eCRFs)
  • Electronical Clinical Outcome Assessment (eCOA), e.g. electronical Patient Reporting Outcome (ePRO)
  • Electronic Electro Cardiogram (eECG)
  • Lung Function
  • Imaging
  • Electronic TMFs (eTMFs)
  • Safety Database
  • Clinical Trial Management System (CTMS)
  • Data Centre
  • IT Operations
  • Software Development

Validation status audits of single computerised systems and/or environments

• We can perform Validation Audits within organisations with the focus on the in house validation of purchased software solutions and their study specific setup (e.g. eCRF, eTMF; CTMS; Safety Databases)