Real Life Sciences

Real Life Sciences (RLS) is a software and services company specialising in clinical trial data anonymization and redaction for pharmaceutical manufacturers, sponsors, and contract research organisations (CROs). The company develops purpose-built technology and provides expert services to help organisations share clinical data and documents with health authorities, partners, internal teams, and publications in compliance with global regulatory requirements.

RLS serves clients navigating a range of regulatory frameworks and voluntary data sharing initiatives, including the European Medicines Agency's Clinical Trial Regulation (EU) 536/2014 and CTIS, EMA Policy 0070, Health Canada's Public Release of Clinical Information (PRCI) programme, and FDA required disclosures. The company works with leading global life sciences companies, industry consortiums, service providers, and regulatory organisations.

RLS Protect — Anonymization and Redaction Platform

• RLS Protect is a software-as-a-service platform designed specifically for sponsors and CROs that must comply with transparency requirements for regulatory bodies and voluntary sharing initiatives.
• The platform offers quantitative risk modelling capabilities, enabling measurement of re-identification risk and data utility to provide confidence to both sponsors and health authorities.
• Document anonymization and redaction tools are included, supporting the preparation of Clinical Trial Report (CTR) documents for publication as well as patient-level datasets.
• RLS Protect supports compliance with Health Canada PRCI, EMA Policy 0070, EMA (EU) 536/2014, and FDA disclosure requirements, as well as voluntary data sharing for secondary research.
• The platform also includes capabilities for protecting confidential information within clinical documents.

Anonymization Strategy and Approach

• RLS recognises that anonymization is not a uniform process; the appropriate strategy depends on the individual characteristics of each project.
• For regulatory submissions involving anonymized personal data — such as those required under EMA Policy 0070 and Health Canada PRCI — a quantitative, risk-based anonymization strategy is recommended, allowing re-identification risk and data utility to be measured objectively.
• When limited patient-level data is involved, a qualitative or rules-based anonymization strategy may be more appropriate.
• RLS assists clients in determining the most suitable strategy for each project, including consideration of potential downstream re-use of data for other purposes.

Anonymization Services

• RLS provides operational anonymization services delivered by a full-time staff team using the company's proprietary technology and a documented methodology.
• Services cover both anonymization and redaction projects, delivered on-time and to quality standards for sponsors and CROs.
• Flexible engagement models are available to align with client priorities and specific project needs.
• The services team supports projects across regulatory disclosure, CTR document preparation, and voluntary data sharing for secondary research.

Regulatory Coverage and Compliance

• EMA Clinical Trial Regulation (CTR) and Clinical Trials Information System (CTIS) under EU 536/2014
• EMA Policy 0070 for publication of clinical data
• Health Canada Public Release of Clinical Information (PRCI)
• FDA required disclosures
• Voluntary data sharing initiatives supporting secondary research and derivative analyses

Learning and Resources

• RLS publishes educational content including blog posts, webinars, events, and podcasts covering anonymization methodology and regulatory developments.
• Topics covered include risk thresholds for patient re-identification, maximising data utility through reference population selection, and handling outlier patients in clinical transparency projects.
• Anonymization resources are available through the RLS Protect section of the platform to support users in understanding and applying anonymization techniques.

RLS describes its solutions and services as regulator-tested and sponsor-approved, with a focus on performance and data security standards. The company maintains a partner network and works alongside leading global life sciences organisations and regulatory bodies.