[INFOGRAPHIC] General Data Protection Regulation (GDPR) and Health Data Challenges

GDPR Clinical Trials Data Anonymization

De-identification involves removing or recoding health information that could identify and individual such as patient identifiers, free text verbatim terms or references to dates. Subsequently, data anonymization involves destroying all links between the de-identified datasets and the original datasets.

Data Anonymization Process & Support

CROS NT offers support for data anonymization compliance starting with patient-level data with a comprehensive process and expert team of statisticians, programmers, medical writers and regulatory professionals. We are both an ISO 9001:2015 and ISO 27001:2014 certified company.

  • Up to Level 3 data privacy protection (risk of data linking)
  • Pre-validated macros less prone to errors
  • 40% faster turnaround time
  • Controlled process
  • Data format specifications required for EudraCT portal data upload
  • Expert consultancy for data transparency strategy
  • CDISC Gold Member