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Protect Patient Identity, Maximize Data Utility and Comply with Regulatory Requirements

Accelerate your internal anonymization processes, leverage a quantifiable risk modeling process, implement high-speed automated redaction, adhere to Health Canada and EMA regulations while maximizing data utility. Support voluntary disclosure using RLS Protect and Managed Services experts.
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Clinical Trial Transparency and Disclosure Regulations

Not Sure How to Best Navigate the Regulatory Puzzle?
We've Got You Covered

RLS has been supporting Sponsor and CRO disclosure submissions for years. We understand the gotchas and how to stay clear of unexpected regulatory hurdles. The team members at RLS pride themselves on partnering closely with our customers and supporting them through the end-to-end process. Manage your business with the confidence that your regulatory submissions are defensible.

EMA (EU) 536/2014

Newly enacted regulation EMA (EU) 536/2014 increases anonymization demands for Disclosure teams. Both an increase in the number of documents subject to redaction of CCI and a greater volume of personal data anonymization are necessary to comply when using the CTIS throughout the trial lifecycle

EMA Policy 0070

EMA Policy 70 seeks to enable the wider scientific community to make use of detailed clinical data to develop new knowledge in the interest of public health.

Health Canada PRCI

Health Canada's objective is to make anonymized clinical information in drug submission applications publicly available for non-commercial purposes following the completion of Health Canada's regulatory review process.

Voluntary Disclosure Policies

Making clinical trial data available for external secondary research or internal sponsor teams comes with its own set of challenges. Ensure your data is shared safely and the patient is protected.

Road Tested - Regulator Proven

Purpose Built to Support Global Regulatory
and Voluntary Data and Document Disclosures

Real Life Sciences Protect is the industry leading solution to automate a fully quantifiable risk modeling, document redaction and anonymization process for your organization. With over 1 million pages and thousands of datasets processed successfully, RLS Protect is purpose built for pharmaceutical Sponsors and CROs to support the growing demands of regulatory bodies, changes in regulations and increased volumes from voluntary sharing requests.

Meet the Demands of (EU) 536/2014

High-Speed Automated Redaction

Disclosure and Transparency teams are facing new pressure points to support increased volumes of documents requiring redaction and strict timelines for protecting personal information and commercial confidential information under the new EMA Regulation (EU) 536/2014 and CTIS. RLS Protect's capabilities are designed for the Life Sciences industry and provide fast, accurate and easy to use functionality to deliver on your regulatory disclosure redaction projects. In addition, RLS's Managed Services team, made up of medical writing and disclosure experts, can act as a natural extension of your team to complete redaction of documents on your behalf.

Stay Ahead of Regulatory Changes

Advanced Anonymization Techniques

By utilizing industry leading technology you will leverage the latest anonymization techniques, even when working with challenging or small subject populations like those found in rare disease trials. Stay ahead of the regulatory curve and minimize your risk by allowing advanced anonymization technology to do the heavy lifting.

Proactively Achieve Success

Plan & Facilitate Regulator Meetings & Discussions

Traditional qualitative redaction approaches do not support the preservation of data utility. Health Canada and EMA expect a quantitative risk modeling methodology for disclosure submissions. Leverage RLS' experience and regulatory knowledge to prepare for your Health Canada's Process Initiation Meeting (PIM). RLS can participate in your PIM meeting(s) and help prepare and present quantitative information that proactively addresses their expectations.

Document & Data Anonymization

Replace Manual, Time Consuming Processes with RLS Protect's Purpose Built Capabilities

RLS Protect delivers repeatable automated workflows to batch process, model and anonymize datasets and documents saving you large blocks of time. Avoid highly manual processes that are difficult to quality control. Minor adjustments to business rules allow you to systematically re-process datasets for regulatory submission and voluntary disclosure –for example, adhering to different risk thresholds based on how the data will be consumed and by whom.

Efficient and Repeatable

Experience Matters:
Real Life Sciences Training and Process Best Practices

RLS provides an extensive range of documentation and training modules that help organizations transition from performing basic redaction and qualitative approaches to more advanced quantitative and automated anonymization processes. Learn of the requirements when submitting documents to Health Canada and EMA, and how to best navigate these processes.
  • Expert advisory services, including webinars and trainer-led tutorials around the latest de-identification techniques and regulatory changes
  • Technical support services, providing end-to-end, production implementation support
  • On-demand anonymization business processing outsourcing to support volume ‘spikes’ in your business

Let us show you how RLS can help.

Data & Document Anonymization Made Easy

We work with leading global life sciences companies, services providers and regulatory organizations.
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Metrics Driven Data Utility Optimization

Metrics Driven Data Utility Optimization (MD-DUO)

Use MD-DUO to take subjectivity out of the equation and provide a definitive set of guidelines from which to base disclosures. Provide regulators with objective data they can rely upon to make clear decisions. Inform Health Canada and EMA ahead of time to accelerate your regulatory disclosure timeline.

We're With You Every Step of The Way

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Our team is made up of passionate leaders in the fields of machine learning, natural language processing, clinical trials, data analysis and regulatory submissions. We help Pharmaceutical Sponsors and CROs focus on your primary business goals while protecting patient identity and company confidential information while maximizing data utility and adhering to regulatory requirements.
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Questions?

Document & Data Anonymization, risk modeling, PIM meetings, regulator feedback, identifying timelines can all be tricky business. Inserting a repeatable process is key for many teams. We have gathered FAQs from Sponsors and CROs we have worked with to provide you with some insight.

Health Canada and the European Medicine Agency require Sponsors to disclose clinical trial results. This includes providing an explanation of how personal information was anonymized so the identity of trial participants remains confidential while the trial results are made public.

Historically, Sponsors simply redacted information pertaining to study results. While redaction keeps personally identifiable information confidential, redaction renders otherwise useful attributes about that data unusable -- for example, a study participant's age, weight or other comorbitities which are relevant to trial results. A quantitative modeling approach uses advanced statistical methods to de-identify the information while maintaining the utility of the data. This allows the information to be useful for the reader of the study results and meaningful for purposes of secondary research by academic institutions and other researchers.

Regulators and Sponsors will accept a measured amount of re-identification risk in order to maintain data utility. Quantitiative risk modeling provides a framework to let you know which data variables must be transformed, which can stay in their original form and which must be redacted to meet the required risk threshholds while balancing protection of personal information.

RLS Protect and RLS Anonymization Services support the following teams: Clinical Operations, Clinical Development, Biostats, Medical Writing, Regulatory & Trial Disclosure Teams.

RLS has extensive experience with disclosure of large and small clinical trial submissions and those with large and very small patient populations. With rare diseases, a more conservative approach/risk threshold is considered (i.e. larger equivalence class sizes). Grouping study participants into larger equivalence classes reduces their identifiability, ensuring we mitigate the risk of re-identification in rare disease studies.

RLS Protect is the industry leading "fit for purpose" solution to support data and document disclosure and anonymization requirements. RLS supports large and small Sponsors and CROs globally. Our Anonymization Services team combines regulatory knowledge with leading edge system capabilities to deliver dozens of EMA and Health Canada submission projects and hundreds of dataset processing and voluntary disclosure initiatives. To date we have processed over one million pages for Pharma organizations.

RLS Protect consists of two interoperable applications that are used to anonymize patient data. The Risk application generates a quantitative risk report, providing the sponsor with the risk metrics and most optimal transformation options to anonymize your data with the confidence that the required risk thresholds are being met while maintaining clinical utility . This report can then be loaded into the Docs application, automating all of the markings into their respective anonymized terms and values, thereby eliminating manual processes and increasing efficiency, accuracy and quality.

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