Real Life Sciences

#ClinicalTrials #DataPrivacy #AdverseEvents #HealthcareInnovation #DataUtility #ClinicalTransparency #TrialDisclosure #ClinicalDisclosure #ParticipantPrivacy #RiskofReIdentification ?? Unlocking Data Utility in Clinical Trials: A Balanced Approach to Adverse Event Assessment and Medical History Anonymization ?? In the complex world of clinical trial transparency, prioritizing patient privacy while maximizing data utility is crucial. Our latest blog dives deep into a hybrid quantitative and qualitative methodology r for effective anonymization and disclosure of Adverse Event (AE) and Medical History data. ?? Key Takeaways: Hybrid Methodology: Discover how we blend quantitative? assessment metrics with contextual insights to retain valuable Adverse Event data while protecting patient privacy. Systematic Assessment Process: Learn about our three-step process for determining? which AE data can be preserved and anonymized while ensuring regulatory compliance. Medical History Anonymization Process: Address the four considerations applicable for Medical History anonymization including Entities, Rules, Conditional areas and standardization for your particular study data Join us in fostering transparency and trust in clinical research! Read the full blog to explore how we're navigating these challenges and setting new standards in clinical transparency:

Please Join Us For Our Next LIVE Webinar: Qualitative Anonymization Best Practices for Policy 0070 and PRCI Disclosure Submissions.

Real Life Sciences was thrilled to sponsor DIA’s Global Clinical Trial Disclosure and Data Transparency Conference last Monday and Tuesday in Arlington, VA. It was a fantastic opportunity to reconnect with old friends and meet new faces in the clinical transparency community. While multiple topics were covered, several insights emerged from the conference related to disclosure submission requirements. The level of engagement from Health Canada and the European Medicines Agency (EMA) was impressive, with representatives addressing several questions from attendees. Representatives from EMA tackled various topics related to EMA Policy 0070 and thoughtfully considered feedback from the audience. Both Health Canada and EMA emphasized the importance of harmonization between health authorities, referencing the new Anonymization Report and the streamlined review process for overlapping documents. Sponsors indicated the progress to harmonize across the two policies is appreciated. However, both agencies acknowledged that there are currently no plans to harmonize timelines between Health Canada and EMA. AI’s role in transparency was another focal point of the conference. Presentations showcased innovative applications of AI in managing large datasets and creating Plain Language Summaries. However, the current limitations of AI were also highlighted, reminding us of the challenges that still exist. If you would like a breakdown on any of the topics covered in the conference, please reach out to us at [email protected] Below is a list of some of the topics discussed at the event: Increase Value of Publicly Disclosed Clinical Trial Information EU Clinical Trials Information System (CTIS) Global Perspectives on Disclosure Enforcement Initiatives by FDA and a UK Research Funding Agency Clarity in Clinical Trials Results Reporting according to EU Clinical Trials Regulation CCI in Clinical Trial Applications and Documents Use of Artificial Intelligence in Clinical Trial Transparency

Please Join Us For Our Next LIVE Webinar: Qualitative Anonymization Best Practices for Policy 0070 and PRCI Disclosure Submissions.

Join us for our next Live Webinar: Optimizing the Disclosure of Adverse Event and Medical History Data While Protecting Participant Privacy in PRCI and Policy 0070 Submissions. Thursday, September 12th at 10am EST. Health Canada and EMA expect Adverse Event data to be disclosed. The decision process around what AE data to retain, anonymize or redact can be complex.? This webinar will examine methodologies you can apply for your PRCI or CDP/Policy 0070 submission project.

Join us for our next Live Webinar: Optimizing the Disclosure of Adverse Event and Medical History Data While Protecting Participant Privacy in PRCI and Policy 0070 Submissions. Thursday, September 12th at 10am EST. Health Canada and EMA expect Adverse Event data to be disclosed. The decision process around what AE data to retain, anonymize or redact can be complex.? This webinar will examine methodologies you can apply for your PRCI or CDP/Policy 0070 submission project.

Real Life Sciences has partnered with Citeline’s Disclose, the industry-leading clinical trial disclosure management solution. The partnership expands the RLS clinical transparency offerings into trial disclosure through the TrialScope Disclose platform. TrialScope Disclose: The most widely trusted solution for clinical trial disclosure management TrialScope Intelligence: A centralized, interactive repository of the critical regulatory knowledge needed for global clinical trial disclosure compliance TrialScope Disclose simplifies the management of increasingly complex clinical trial disclosure. Using these robust solutions takes the manual strain out of maintaining disclosure compliance. For further information on how our collaborative efforts can benefit your organization, please feel free to message us at [email protected].

Key Considerations: Disclosing Clinical Study Reports Under EMA CTR As some of the initial studies that started in CTIS and transition studies begin to come to a close, it is important to plan ahead for the required disclosure of CSRs. Per Article 37 of CTR, the authorization holder must upload the CSR to CTIS within 30 days after the marketing authorisation has been granted by EMA or the marketing authorisation has been completed, or the applicant for the marketing authorisation has withdrawn the application. Keep in mind the moment a CSR is submitted, the information contained in the CSR will become public. Plan ahead for the required timing to upload the CSR. Questions? Contact RLS. [email protected]