Data and Document Anonymisation Services

Ensure Your Clinical Trial Data Transparency and Privacy

Regulatory-compliant anonymisation solutions to protect patient privacy while enhancing data accessibility.

With increasing emphasis on clinical trial data transparency comes the regulatory requirement to anonymise study and company data to safeguard patient privacy. This anonymisation occurs at both the document and data set level. Ensuring anonymisation compliance is complex and involves careful redactions and removal of personal data across the entire biometric process of drug development.

At Quanticate, we provide expert anonymisation services to ensure compliance with regulatory requirements, enabling seamless registration and submission of your trials to the appropriate agencies.

Our Services

Our team specialises in providing expert solutions for safeguarding sensitive information while maintaining data utility. We tailor our services to meet your organisation’s unique requirements for data retention, redaction, and anonymisation, ensuring compliance with global regulations.

Anonymisation with Redaction Only Approach

We offer accurate redaction and anonymisation services that prioritise the protection of sensitive data. Utilising qualitative and quantitative risk assessments, we provide actionable insights, minimise uncertainty, and ensure compliance with your specific data protection needs.

Redaction with Data Transformation

Our approach transforms identifying information while employing quantitative risk assessments. By delivering clear, data-driven analyses, we help organisations understand and mitigate potential risks, safeguarding privacy and regulatory compliance.

Clinical Dataset, Document, and DICOM Image Anonymisation

We synchronise the anonymisation of clinical datasets, documents, and medical images (DICOM) for a unified study strategy. Adhering to GDPR-compliant techniques and DICOM standards, we remove or encrypt personally identifiable data while preserving research and clinical utility.

Protection of Personal Protected Data (PPD) and Commercially Confidential Information (CCI)

We ensure the privacy and security of PPD and CCI through tailored solutions that protect sensitive information during sharing, reporting, and storage.

Quantitative Risk Assessment for Anonymised Documents

Our quantitative assessments evaluate and mitigate risks associated with document anonymisation, providing data-driven clarity and confidence.

Anonymisation Reports

Our detailed anonymisation reports validate compliance with regulations and document the processes undertaken to ensure data protection.

Protocol Design and Power Calculations

Get the right protocol design for the right scientific questions of…

Data Sharing and Collaboration

We enable seamless data sharing and collaboration with researchers and stakeholders, supporting clinical data transparency and other initiatives while safeguarding privacy and confidentiality.

Data Anonymisation Specialists

At Quanticate our statistical programmers provide data anonymisation to support with your data transparency efforts. Our programmers experts have developed sophisticated macros to automate the creation of high-quality anonymised datasets. The anonymised datasets are compliant to transparency requirements as they are traceable by implementing CDISC standards. With the use of both SDTM and ADaM, datasets met the criteria needed for data transparency compliance.

These processes can be used across multiple studies and we can anonymise at individual patient level data across formats such as SAS Transport files, SAS7BDAT, Excel and CSV. Our team are up to date on the latest EU data transparency legalisation and can help consult you on the best way to make your data publicly available.

Our Data Anonymisation Strategy

Our data anonymisation process includes the following:

Rule sheets and anonymisation keys
Risk assessment report
Audit trail and reports on steps to create your anonymised datasets
Based on PhUSE guidelines and EMA Policy 0700, FDA, Transcelerate and Health Canada guidance
Advanced macros and latest CDISC standard implementation
Ability to integrate with data sharing systems

Regulatory Compliance

We ensure adherence to global regulatory requirements to enable seamless submission and transparent data by collaborating closely with sponsors to align processes with the following standards - EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation (CTR), as well as the PhRMA, EFPIA, and ICMJE Guidelines.

Why Partner with Us?

Access to Expertise at Every Level

Our flat hierarchal company structure provides you with direct access to our entire team, from analysts to our COO's. Founded by statisticians who understand the clinical trial process end-to-end, we ensure agile, informed support at every stage, enhancing efficiency and alignment with your objectives.

Transparent Partnership, Built for You

We pride ourselves on openness and honesty in every engagement, tailoring our services around your unique needs. Our goal is to offer solutions that maximise the value of our expertise for you, ensuring your trial is optimised for efficiency and meaningful data outcomes, whilst maintaining patient confidentiality.

Integrated Cross-Functional Capabilities

Our medical writing team works seamlessly with CDM and statistics to ensure aligned database lock timings, standardized datasets, and precise document formatting. By integrating anonymization processes and leveraging advanced technology, we safeguard patient privacy while delivering high-quality, regulatory-ready results efficiently.

Over 30 Years of Specialised Expertise

As one of the world’s largest global biometric & data CRO’s, we bring deep technical knowledge to data anonymisation, processing, analysis, and regulatory compliance. Our expertise spans all phases and therapeutic areas, enabling us to deliver high-quality, reliable solutions tailored to the complex and evolving needs of every clinical trial.

Team Leaders

Karen Ooms

Joint Chief Operating Officer

Karen Ooms is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a Senior Statistician at Unilever.

Data and Document Anonymisation Services

Ensure Your Clinical Trial Data Transparency and Privacy

Our Services