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Echoing Max's excitement to launch HTA Vision! A powerful new tool for market access executives and teams to be empowered with the latest insights and intelligence from the world of global HTA. Join our webinar on June 13th to learn more. #HTA, #MarketAccess

Clinical trials at AMCs and health networks face unique challenges, especially during the start-up phase. Traditional, paper-based regulatory documentation often slows things down, creating bottlenecks in a complex, multi-layered process. Our latest blog unpacks eReg/eISF systems can speed up clinical trial start-up times, reduce administrative burdens, and improve compliance, allowing trials to operate with unprecedented efficiency. Here’s a quick preview of the key benefits: →Faster Start-Up Timelines: eReg/eISF reduces protocol review time by centralizing and automating document management, cutting study start-up timelines by up to 20% for our clients. Say goodbye to physical handovers and fragmented systems! →Improve Compliance & Audit Readiness: With automated audit trails and version control, eReg/eISF ensures that all regulatory requirements are met without extra hassle. In fact, RealTime users report 5x more inspection readiness with eReg/eISF platforms. →Better Stakeholder Collaboration: eReg/eISF enables real-time document sharing, making it easier for AMCs, sponsors, and regulatory agencies to stay aligned. Remote access and eSignatures further facilitate smooth workflows and uninterrupted operations. →Integrated Systems for Seamless Operations: eReg/eISF integrates easily with other clinical trial management systems, allowing better coordination and faster document retrieval, leading to 75% reduced monitoring costs in among many RealTime clients. 🔗 Check out the full breakdown on how eReg/eISF can accelerate clinical trial cycle times right here: https://lnkd.in/e5wS9c2E #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData 

Beyond excited to launch HTA Vision — a powerful new tool for market access executives and teams to be empowered with the latest insights and intelligence from the world of global HTA. Join the Trinity Life Sciences webinar on June 13th to learn more.

📢 ICH Harmonized Guideline E6(R3): Setting New Standards for Good Clinical Practice (GCP) The International Council for Harmonization (ICH) has released the much-anticipated E6(R3) Guideline for Good Clinical Practice (GCP), marking a significant milestone in global clinical research. This updated guideline reflects the evolving landscape of clinical trials, integrating modern approaches, technological advancements, and a focus on participant safety and data integrity. Key highlights include: 🔹 Enhanced risk-based quality management strategies. 🔹 Increased emphasis on ethical considerations and participant rights. 🔹 Guidance on leveraging digital tools for trial oversight and documentation. 🔹 Flexibility to adapt to innovative trial designs and real-world evidence. At Zyfis Lifesciences, we are committed to aligning our clinical research practices with these globally harmonized standards, ensuring compliance, efficiency, and reliable outcomes for every study we manage. Let’s work together to uphold the highest standards of clinical research! 🌍 #GoodClinicalPractice #ICHGuidelines #E6R3 #ClinicalResearch #ZyfisLifesciences #EthicsInResearch #QualityManagement #ClinicalTrials

Effective Sponsor Oversight: Ensuring Clinical Excellence! In the dynamic landscape of #clinicalresearch, sponsor oversight emerges as a critical linchpin. It’s not merely about ticking boxes; it’s about orchestrating a symphony of safety, quality, and compliance. 🔍 Why Sponsor Oversight Matters: 1. Patient Safety: Ensuring the well-being of trial participants is non-negotiable. Oversight bridges the gap between protocols and real-world execution, safeguarding those who entrust us with their health. 2. Data Integrity: High-quality data fuels scientific progress. Rigorous oversight ensures that data collection, management, and reporting align with best practices and regulatory standards. 3. Regulatory Compliance: The inspector’s question looms: “How have you ensured compliance?” Our answer lies in meticulous oversight—documented, proactive, and aligned with ICH E6 (R2) and EU Clinical Trial Regulation 536/2014. 🌐 The Art of Oversight: Imagine it as a finely tuned instrument. We harmonize preclinical insights, manufacturing perspectives, and #clinicalstudy design. The result? A symphony of confidence in our trial conduct. 🎶 🎓 Learn More: Explore our comprehensive course on Getting the Right Level of Sponsor Oversight. Discover practical strategies, regulatory insights, and real-world examples here: https://lnkd.in/ece42RiW 📧 Contact us at info@eccrt.com #Training #SponsorOversight #ECCRT #RegulatoryAffairs #EUCTR

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AMCs and health networks face significant challenges in maintaining operational efficiency, data integrity, and regulatory compliance. One pivotal strategy to navigate this challenging environment is the effective capture and tracking of key performance metrics. These clinical trial performance metrics offer vital insights that can guide AMCs in fine-tuning their trial processes and achieving better outcomes. However, the task of managing these metrics can often become overwhelming. Enter RealTime-Devana, a purpose-built platform designed to simplify the clinical trial process by capturing, displaying, and optimizing key clinical trial performance metrics throughout the entire trial lifecycle. Whether the trials are investigator-initiated, grant-funded, or industry-sponsored, Devana provides true end-to-end visibility and operational oversight that allows research organizations to operate more efficiently and make informed, data-driven decisions.  👉 Keep reading: https://lnkd.in/gvcbhafH #trialperformance #dataanalytics #clinicaltrials #clinicalresearch #Devana

🚀 𝐋𝐚𝐮𝐧𝐜𝐡𝐢𝐧𝐠 𝐌𝐲𝐭𝐡 𝐕𝐬 𝐅𝐚𝐜𝐭 𝐒𝐞𝐫𝐢𝐞𝐬 There are so many myths surrounding Clinical Trials, their processes, and even some of the roles within the industry! These misconceptions can create confusion and mislead people, which is why I’m launching a special series called "𝐌𝐲𝐭𝐡𝐬 𝐯𝐬 𝐅𝐚𝐜𝐭𝐬" to share some of the most common myths vs the fact. For the next 𝐭𝐰𝐨 𝐰𝐞𝐞𝐤𝐬, I’ll be sharing insights on various myths that are often believed to be true in the world of clinical research—whether it’s about trial designs, monitoring, or the responsibilities of clinical roles. 𝐇𝐞𝐫𝐞 𝐢𝐬 𝐭𝐡𝐞 𝐟𝐢𝐫𝐬𝐭 𝐩𝐨𝐬𝐭 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐬𝐞𝐫𝐢𝐞𝐬! 💡  𝐑𝐢𝐬𝐤-𝐁𝐚𝐬𝐞𝐝 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 (𝐑𝐁𝐌) has been a significant shift in the world of clinical trials over the past few years, moving away from traditional on-site monitoring to a more data-driven and targeted approach. RBM focuses on identifying, assessing, and mitigating risks throughout the clinical trial process, allowing sponsors to prioritize critical data points and sites for oversight. As the industry recognized its efficiency and effectiveness, RBM gained immense visibility and adoption across trials globally. However, with this growing adoption, misconceptions and myths have also emerged, often due to a lack of understanding or experience with this model. 𝐇𝐞𝐫𝐞 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐭𝐨𝐩 𝐓𝐇𝐑𝐄𝐄 𝐦𝐲𝐭𝐡𝐬 I've encountered during conversations with professionals. 𝐈’𝐝 𝐥𝐨𝐯𝐞 𝐭𝐨 𝐡𝐞𝐚𝐫 𝐲𝐨𝐮𝐫 𝐭𝐡𝐨𝐮𝐠𝐡𝐭𝐬 𝐚𝐧𝐝 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞𝐬—𝐬𝐡𝐚𝐫𝐞 𝐲𝐨𝐮𝐫 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬, 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞𝐬, 𝐨𝐫 𝐛𝐮𝐬𝐭 𝐬𝐨𝐦𝐞 𝐦𝐲𝐭𝐡𝐬 𝐲𝐨𝐮𝐫𝐬𝐞𝐥𝐟! #clinicalresearch #qualitymanagementsystem #goodclinicalpractices #ICHGCP #Riskbasedmonitoring #RBM #remote #MythsVsFacts #GCP #ClinicalTrials #Monitoring #ClinicalDesign #remoteMonitoring #GlobalClinicalTrials #Quality #QualityAssurance

An increase in clinical trial data is driving demand for enhanced clinical trial processes. Sponsors want to be able to review data which has been analyzed quickly and efficiently so they can make informed decisions faster. CluePoints' François Torche, is featured in the Journal for Clinical Trials discussing the benefits of risk-based quality management (RBQM) in this high-volume landscape. Read the full article to learn how RBQM offers an opportunity to improve data quality and integrity, while still creating much-needed efficiencies: https://lnkd.in/g8McRSUm #RBQM #DataQuality #Innovation

The introduction of Joint Clinical Assessments (JCAs) marks one of the most significant changes in the European healthcare landscape in recent years. It’s a game changer for accelerating patient access to new health technologies. Here's a great update by my colleagues Darata Žemaitaitytė & Mark Chalmers and the Life Sciences team at EY. Together, we supported a large pharma company in preparing for these changes and identifying new opportunities in this evolving regulatory environment. Check it out below 👇 https://lnkd.in/ej9eNcGY #HTAR2025