Making clinical research crystal clear

Redaction and anonymisation services

Data privacy is important. Patients and the public are demanding more transparency in clinical research. In response, regulatory authorities, including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Health Canada (HC), require clinical trial sponsors to make clinical trial documents publicly available. These documents may contain protected personal data (PPD) which is information that could be used to identify individuals. Commercially confidential information (CCI) may also be present in these documents. Clinical study sponsors must anonymise PPD and CCI to reduce the risk of participant identification and protect CCI. They must achieve this without reducing the scientific utility or value of the documents.

Krystelis Services in Support of EU CTR 536/2014

Krystelis Services in support of EMA Policy 0070 and Health Canada Policy on the Public Release of Clinical Information (PRCI)

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Redacting and/or anonymising documents to meet regulatory requirements can be time-consuming and technically challenging. Many sponsors outsource this to specialised vendors.

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We offer a full-end-to-end document redaction and anonymisation service

Assessment of source documents for PPD

Re-identification risk-assessment

Preparation of an anonymisation plan

Identification of CCI

Literature search to confirm CCI

Anonymisation/redaction of PPD

Redaction of CCI and preparation of justification table/proposed redaction control sheet

Preparation of the anonymisation report

Krystelis Subject Matter Experts (SMEs) have been working in this area since 2012. During this time, they have supported redaction and anonymisation activities for many clinical trial sponsors, from small biotechs to top-10 pharmaceutical companies (Figure below):

Benefits of working with Krystelis

Deep expertise in all policies and guidelines, anonymisation techniques, GDPR and HIPAA

Our experience of voluntary data-sharing requests, investigator requests, and regulatory obligations

Our experience in gap analysis and preparing redacted documents in compliance with EU CTR

We have prepared redacted packages under EMA Policies 0043 and 0070, HC PRCI, PMDA and BfArM

Our experience liaising with regulators for consultation and comment resolution

Insights gained from our contributions to industry forums (DIA, PHUSE, and Informa Connect)

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