RLS Protect

RLS Protect is a document and data anonymization platform developed by Real Life Sciences, designed for pharmaceutical Sponsors and Contract Research Organizations (CROs). It supports regulatory disclosure submissions to bodies including the EMA and Health Canada, as well as voluntary data sharing initiatives. The platform combines automated redaction, quantitative risk modeling, and advanced anonymization techniques to help organizations protect patient identity while preserving data utility across clinical trial datasets and documents.

RLS Protect is built specifically for Life Sciences teams including Clinical Operations, Clinical Development, Biostats, Medical Writing, and Regulatory and Trial Disclosure teams. With over one million pages and thousands of datasets processed, the platform addresses growing regulatory demands and increasing volumes from voluntary sharing requests.

Regulatory Frameworks Supported

• EMA (EU) 536/2014 and CTIS: addresses increased volumes of documents requiring redaction of commercial confidential information (CCI) and greater personal data anonymization demands throughout the trial lifecycle.
• EMA Policy 0070: supports disclosure of detailed clinical data to the wider scientific community for public health purposes.
• Health Canada PRCI: facilitates the public availability of anonymized clinical information from drug submission applications following Health Canada's regulatory review.
• Voluntary Disclosure: supports safe sharing of clinical trial data for external secondary research or internal sponsor teams, with controls to protect patient identity.

High-Speed Automated Redaction

• Provides fast, accurate redaction functionality designed for the Life Sciences industry to meet strict timelines under EMA Regulation (EU) 536/2014 and CTIS.
• Handles increased volumes of documents requiring protection of personal information and commercial confidential information.
• RLS Managed Services, staffed by medical writing and disclosure experts, can act as an extension of a customer's team to complete document redaction on their behalf.

Advanced Anonymization Techniques

• Applies the latest anonymization methods, including support for challenging or small subject populations such as those found in rare disease trials.
• Uses larger equivalence class sizes for rare disease studies to reduce participant identifiability and mitigate re-identification risk.
• Supports a quantitative risk modeling methodology expected by Health Canada and EMA, as opposed to traditional qualitative redaction approaches that reduce data utility.

Quantitative Risk Modeling

• Provides a framework to identify which data variables must be transformed, which can remain in their original form, and which must be redacted to meet required risk thresholds.
• Balances protection of personal information with preservation of data utility for readers and secondary researchers.
• Allows different risk thresholds to be applied depending on how data will be consumed and by whom, enabling systematic reprocessing for different disclosure contexts.
• RLS can participate in Health Canada's Process Initiation Meeting (PIM) and help prepare and present quantitative information that addresses regulator expectations.

Document and Data Anonymization Workflow

• RLS Protect consists of two interoperable applications: the Risk application and the Docs application.
• The Risk application generates a quantitative risk report with risk metrics and optimal transformation options to anonymize data while meeting required thresholds and maintaining clinical utility.
• The risk report is loaded into the Docs application, which automates the application of anonymized terms and values, eliminating manual processes and improving efficiency, accuracy, and quality.
• Supports batch processing of datasets and documents through repeatable automated workflows.
• Minor adjustments to business rules allow systematic reprocessing of datasets for different regulatory submissions or voluntary disclosure requirements.

Training, Support, and Managed Services

• Provides documentation and training modules to help organizations transition from basic redaction and qualitative approaches to quantitative and automated anonymization processes.
• Offers expert advisory services including webinars and trainer-led tutorials covering the latest de-identification techniques and regulatory changes.
• Provides technical support services with end-to-end production implementation support.
• Offers on-demand anonymization business process outsourcing to support volume spikes.
• Team expertise spans machine learning, natural language processing, clinical trials, data analysis, and regulatory submissions.

RLS Protect is used by leading global life sciences companies, service providers, and regulatory organizations. The platform and associated Managed Services team have supported dozens of EMA and Health Canada submission projects and hundreds of dataset processing and voluntary disclosure initiatives.