ANONYMIZATION OF DOCUMENTS AND DATA SETS

MMS can help you achieve compliance while protecting patient and company information at the same time.

Our cross-functional team of experts ensures the highest level of data utility.

Anonymization and Redaction of Documents Services

MMS is an innovator of risk-based clinical trial document anonymization, with industry thought leadership and the use of advanced tools to achieve both efficiency and quality in every deliverable. Internal anonymization processes and tools are designed to maximize data utility and protect patient privacy at the same time.

We offer:

  • Document anonymization and/or redaction
  • Assessment of confidential proprietary information
  • Streamlined process for meeting regulatory requirements
  • Quantitative risk assessment for anonymized documents
  • Anonymization reports

The flexibility of our teams is key in preparing large projects, compliance to EMA Policy 0700, HC PRCI, or EU CTR Regulations, data sharing and collaboration with researchers, and other transparency initiatives.

To ensure the highest level of data utility, all document anonymization work is performed by a cross-functional team, including clinical trial data analysts, biostatisticians, and medical writers, with the ability to anonymize studies in batches.

Anonymization of Data Services

MMS’ risk-based dataset anonymization approach protects patient privacy and maximizes the data utility by keeping the risk below our predetermined threshold. Our process is proven to produce high-quality anonymized datasets with less manual effort. The anonymization of each variable is driven by a standard rule set that can be reused across multiple studies. Our rule-building technology allows us to switch rules based on the personal information in each variable. Our tool can anonymize individual patient level data in different data sources, including SAS transport files, SAS7BDAT, Excel, and CSV.

Key highlights to our process:

  • Designed based on EMA Policy 0700, Health Canada, FDA, Transcelerate, and PhUSE guidelines
  • Integrated risk-based data anonymization
  • Rule-building technology
  • Balanced privacy and data utility
  • Secure cloud-based SaaS
  • Available integration with data-sharing platforms
  • Comprehensive report and audit trail

Anonymization deliverables include:

  • Anonymized datasets
  • Anonymization and risk assessment report
  • Rules sheet
  • Anonymization keys

The MMS Difference

The clinical trial transparency team is dedicated to delivering high-quality documents and data, ensuring the protection of personal and confidential information, while balancing data utility. This is accomplished through the efforts of our global team members, subject matter experts, and preferred partnership with industry-leading technologies.

The clinical trial transparency team aspires to exceed our Sponsors’ expectations using risk-based assessment and transformation of data in their clinical study documents. With our proven processes and preferred partnerships with industry-leading technology, we strive to provide anonymized documents with maximum data utility in alignment with global regulatory agency expectations and guidelines. Our goal is to maintain a customer focus throughout the product lifecycle, ensuring the customer experience is positive, trust is built, and we create long-term relationships.

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