Data Anonymization
With the increasing demand for transparency through regulations such as the European Union Clinical Trial Regulation (EU CTR), Policy 0070/0043, Health Canada Public Release of Clinical Information (PRCI), it is crucial to ensure that protected personal data (PPD) and commercially confidential information (CCI) are responsibly redacted and anonymized to prevent the identification of study participants as well as protect CCI. Without adequate support, such tasks can be demanding and lead to error.
Our expert team has delivered over 5,500 documents, 30 submissions, and 30 anonymization reports in support of EMA Policies 0070 and 0043, Health Canada, and corporate transparency policies. In our strategic engagements, we work with our clients to ensure appropriate SOP creation and compliance as well as alignment on approach to anonymization.
Working with our consultants has the following benefits:
Deep understanding of all guidelines and regulations
Accelerated redaction turnaround times
Significant expertise liaising with regulators
Strategy and project management support
Anonymization and Redaction Services offered
Redaction strategy consultation / risk assessments
Preparation of anonymization plans and final reports
Data anonymization/redaction services for CTIS, manuscripts, CTgov, Policy 0070, and PRCI
Training workshops
Anonymization & Redaction Partners
ClaritiDox provides tech-enabled anonymization and redaction services when appropriate through our partnerships.
What our clients say
"We have partnered with ClaritiDox for several years to prepare numerous anonymized clinical application packages for public disclosure. ClaritiDox personnel dedicated to our projects do an impressive job keeping company redaction rules and processes specific to our packages while working across diverse client rules and processes, and meeting or exceeding document preparation timelines. The ClaritiDox team are professional and collaborative and a pleasure to work with.”
Associate Director of Disclosure
- Large Pharma Company