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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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