An innovator delivering advanced research clinical trial data anonymization: Real Life Sciences

Borne from purpose-built advanced Artificial Intelligence for the Pharmaceutical industry, Real Life Sciences (RLS) brings patient centricity to the forefront by amplifying the patient voice with Social Media Epidemiology insights and providing the industry's leading clinical disclosure and anonymization solution. PROTECT is the leading data and document redaction and anonymization solution designed specifically for Sponsors and CROs who comply with disclosure and transparency requirements for regulatory bodies and voluntary sharing initiatives. PROTECT offers the most advanced quantitative risk modeling, document anonymization and redaction capabilities enabling your organization to scale and support the increasing demands of Health Canada PRCI, EMA Policy 0070, EMA (EU) 536/2014 as well as data sharing partners.

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

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

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. 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.

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. 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. 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.

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

Document & Data Anonymization

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 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 RLS mitigates 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. RLS’ 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 RLS has 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.

Advanced RealNLP

When it comes to real world social media data solutions, all are not created the same. Social media listening is commonly used but comes up short. The key is to have the best data and this doesn’t cut it. RLS Reveal is not only able to "listen" to what is happening on social media, but it is able to structure all of these key opinions and produce outputs that can be actionable for your team. Real Life Sciences also specializes in clinical trial disclosure and transparency. RLS Protect anonymizes trial participant data. RLS uses this same technology to protect sensitive information in Social Media Posts. Natural Language processing has been trained for over 6 years. Utilizing machine learning and AI to continually improve - Noise elimination for clean accurate data - Identification of patient journey trends, perceptions and behaviors - And the use of purpose built insights driving better outcomes.

Elliot Zimmerman, CEO

“At RLS, we understand that we protect not just data but we protect patients. Partnering with our team takes the stress and ambiguity out of voluntary and regulatory data sharing.”

“Whether it's clinical trial disclosure submissions for Health Canada PRCI or EMA, or voluntary data sharing projects, you can depend on our deep expertise and breadth of experience to deliver success.”