Olio’s Post

🌍 Exciting Update from the ICH Assembly! The ICH E6(R3) Annex 2 is making significant strides, as confirmed during the recent ICH Assembly meeting in Montreal this November. 📅 This key update is a major step forward in enhancing the quality, efficiency, and integrity of clinical trials worldwide. As the global landscape of clinical research continues to evolve, these updates will play a crucial role in improving patient safety 👩🔬, streamlining regulatory processes ✅, and driving innovation 💡 in clinical trials. 🔜 Stay tuned as ICH continues to lead the way in modernizing global clinical trial standards and paving the path toward a brighter, more efficient future in research. 🚀 👉 Read more about the ICH Assembly meeting and updates here: https://lnkd.in/evMB3WNY #ICH #ClinicalTrials #ICHAssembly #ICHguidelines #E6R3 #InnovationInResearch #PatientSafety #GlobalHealth

Have you booked a funded (free) ticket yet..... 𝐃𝐞𝐜𝐨𝐧𝐭𝐚𝐦𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐒𝐭𝐞𝐫𝐢𝐥𝐢𝐬𝐚𝐭𝐢𝐨𝐧 𝟐𝟎𝟐𝟓 - 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐃𝐚𝐭𝐞: 29th April 2025 𝐕𝐞𝐧𝐮𝐞: The National Conference Centre 𝐃𝐞𝐭𝐚𝐢𝐥𝐬: Our annual DAS conference brings together leading experts to discuss decontamination and sterilisation practices. https://lnkd.in/en43uemF - Use code 𝐃𝐀𝐒6

🔍 ICH E6(R3): A New Era in Good Clinical Practice (GCP) 🔍 The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period. With a focus on adaptability and flexibility, the update addresses the increasingly diverse trial types, innovative methodologies, and data sources shaping the future of clinical research. 📌 What’s New in E6(R3)? - Overarching Principles: Enhancing reliability, quality, and patient safety across all trial types. - Annex 1: Detailed operational guidance for trial conduct, including risk-based approaches and data integrity. - Annex 2: A specialized focus on decentralized trials, adaptive designs, and the integration of real-world data. 📌 Key Updates: 1) Decentralized Trials: Guidelines for conducting trial activities outside investigator sites, such as home visits or remote data collection using digital health technologies (DHTs). 2) Pragmatic Trial Designs: Emphasizes simplified protocols and streamlined data collection to align with real-world clinical practices. 3) Real-World Data (RWD): Provides considerations for integrating data from sources like electronic health records (EHRs) and registries, while ensuring data quality, privacy, and regulatory compliance. 4) Patient-Centricity: Enhances informed consent processes with remote options and tailored materials to improve accessibility and understanding. 5) Sponsor Oversight: Strengthens accountability for decentralized trial operations, investigational product management, and multi-source data reliability. 📅 Key Timelines - Public Consultation Deadlines: MHRA (UK): 14 February 2025, TFDA (Chinese Taipei): 28 February 2025 This update reflects the growing importance of harmonizing global regulations while embracing innovation and evolving clinical trial designs. #ICH #GCP #ClinicalTrials #E6R3 #InnovationInResearch #ClinicalResearch #CRO #CNRResearch

Directories that connect you with real health experts, at no cost! I’ve been putting digital foot to pedal and growing resources for the world at large, at THE healthcare innovation hub. Just finished editing and publishing a step-by-step video on how to use our directories, showing you ways in which they can be used. Next week: the unveiling of our newest DIRECTORY, for those of you who have services you’d like to showcase to doctors, called Experts for Doctors. It’s all part of a site that’s part health media, part healthcare publicity. We’re making connections and changing the way healthcare impact is made. How to use then: https://lnkd.in/eajAQx_W The Directories: https://lnkd.in/ekPVxeck

Looking to boost your revenue capture strategies? Don’t miss Ken J.'s November 4, 1:30PM educational session where he will share real-world examples and proven strategies of how to convert contract underpayment and claim denial revenue losses into sustainable gains . While you’re there, say hi to Lance Seach who will also be attending the conference! #HFMA2024 #RevenueOptimization #HealthcareSolutions #SlicedHealth #contractmanagement, #businessintelligence

Timing and preparation are key! Make sure your documentation is airtight before involving your congressperson. Listen in to our discussion on this topic: https://lnkd.in/erEi--5q #ThePilotLawyer #FAACertification #CongressionalInquiries

🌟 Updates in the ICH GCP E6(R3) Guideline – A Step Forward for Modern Clinical Trials 🌟 The ICH Good Clinical Practice (GCP) E6 guideline has been officially updated to its third revision (E6(R3)) as of January 2025. Changes aim to make the guidelines more adaptable to current technologies, address ethical considerations in diverse populations, and ensure the quality and reliability of trial data. 📌 What's New in E6(R3)? 1️⃣ Risk-Based Approaches: Enhanced focus on quality by design (QbD) principles and risk-based monitoring to streamline trial processes. 2️⃣ Digital and Data Integrity: Improved guidance on managing electronic records and integrating digital tools into clinical research. 3️⃣ Decentralized Trials (DCTs): Inclusion of strategies to support decentralized and hybrid trial designs for greater flexibility. 4️⃣ Diversity and Inclusion: Strong emphasis on participant diversity and equitable access to trials globally. 5️⃣ Efficiency and Innovation: Recommendations to improve trial efficiency and adapt to the needs of modern research practices. 6️⃣ Sustainability: Considerations for environmentally sustainable practices in clinical trials. This revision represents an important step in fostering global harmonization and enhancing the quality and efficiency of clinical trials, benefiting sponsors, investigators, and—most importantly—patients. 💬 How do you see these updates shaping the future of clinical trials? Are there particular aspects of E6(R3) that resonate with your organization? Let’s discuss! #ICHGCP #E6R3 #ClinicalTrials #DecentralizedTrials #DiversityAndInclusion #PharmaInnovation #ClinicalResearch #CRORole #CRO #CNRResearch https://lnkd.in/gH9FgpuV

Three recent resolutions/guidelines represent a significant milestone for public, community and patient engagement with health research worldwide: WHA 75.8, WHO guidelines for best practices in clinical trials and the declaration of Helsinki. https://lnkd.in/d4rrSYYM The Global Health Network #communityengagement #publicengagement #patientengagement

New on the Lumos blog: Understanding and navigating the complexities of IRBs. Get tips on how to submit protocols, work with your IRB, and stay compliant! https://lnkd.in/e3JvtYfk

Boost your export expertise! Whether you're new to exporting or just need a refresher, don't miss the Society of International Affairs (SIA) 2025 Winter Back to Basics Virtual Conference! Registration is now open for this 5-day virtual event, happening February 24-28 from 1pm-5pm ET. Secure your spot and enhance your knowledge of export regulations and best practices. Register now and take your exports to the next level! #exportcompliance #tradeeducation #SIAconference