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EDC Consulting

Our consultants will help you to reach the optimal use of new IT technologies in the process of collecting critical and sensitive data (electronic data capture "EDC"):

  • eCRF, ePatient Diary (ePro, eCOA) and BYOD
  • "Wearable devices"
  • CTMS
  • Lab e-book, LIMS
  • Electronic Signature
  • Data Management & Data Coding (MedDRA)
  • Audit Trail
  • Sensitive Data Hosting (security)
  • Data Integrity
  • Storage and long term Archiving of digital data
  • Systems Validation according to regulations, guidances, guidelines and standards:
    • GxP, ICH
    • FDA (21 CFR part 11), UE (Annex 11), CNIL
    • GAMP
    • PIC/S
    • CDISC, HL7
  • Quality Assurance

 

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