Lucid Group’s Post

Happy to share these insights on the revision to Good Clinical Practice (ICH E6 R3). Click on the report below for details.

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

Think less complexity, more clarity. Think less spreadsheets, more innovation. Think #OPRA. But we don't only want you to think it. Let us show you just how #OPRA can transform your clinical trials, allowing patient safely, data integrity, and regulatory compliance. During August, we'll be running two live demos of our #RBQM platform, #OPRA. The first will be the Central Monitoring module, the second will be Risk Assessment & Management. Each one is just 30 minutes long, and free to join. #OPRA Central Monitoring Thursday 8th August https://lnkd.in/eUmTKsXN Central monitoring is the key to effective clinical study management and efficient use of resources. This introduction to TRI’s OPRA CM platform will demo how trends and outliers can be used to course correct clinical studies, prevent delays, and focus monitoring resources. #OPRA Risk Assessment and Management Thursday 22nd August https://lnkd.in/eCjzNqDy Assessing, managing, and minimising risks to clinical studies is not just a regulatory requirement. It’s at the heart of good RBQM, improving the likelihood of studies running smoothly and to time, and minimising risks to data quality and patient safety. This webinar gives an overview of how OPRA-RAM makes risk assessment & management, easier, more effective, and regulatory compliant!  Sponsors and CROs Only #OPRA #RBQM #RBQMtechnology #riskassessment #centralmonitoring #livedemo #clinicaltrials #compliant #ICHE6R2

TRI's #OPRA solution can transform clinical trials, improving patient safely, data integrity, and regulatory compliance. Additionally, intelligent application of TRI's #RBQM solutions can better direct your monitoring strategy and save costs! $$$ ! You've nothing to lose and plenty to gain so sign up for this FREE Webinar by following the link below! #clinicalinnovation #RBCDM #monitoring #centralizedmonitoring

🔍 Unlocking Insights with RBQM in Centralized Monitoring 🔍 Centralized Monitoring is revolutionizing how we oversee clinical trials, and Risk-Based Quality Management (RBQM) is at its core. By harnessing advanced analytics and real-time data, RBQM in centralized monitoring allows us to detect risks early, ensure protocol compliance, and enhance data quality across global studies. Gone are the days of manual checks and reactive measures. With RBQM, we proactively identify trends, outliers, and potential issues, empowering teams to make informed decisions swiftly. This approach not only strengthens patient safety but also accelerates trial timelines and optimizes resource allocation. Let's embrace RBQM in centralized monitoring to drive efficiency, uphold quality standards, and pave the way for innovative treatments that transform lives. #RBQM #CentralizedMonitoring #ClinicalTrials #DataAnalytics #PatientSafety #InnovationInHealthcare #ClinicalResearch

Looking forward to be speaking on the panel session “𝗥𝗕𝗤𝗠 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗘𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻 – 𝗔𝗱𝗮𝗽𝘁𝗶𝗻𝗴 𝘁𝗼 𝗠𝗼𝗱𝗲𝗿𝗻𝗶𝘇𝗮𝘁𝗶𝗼𝗻" at #RBQMLive2024. Are you interested to know more about the opportunities and challenges with the evolving guidance updates, strategies for integrating quality by design into clinical trials and execution and approaches to ensure inspection readiness? Join us! Registration is still open. #JuliusClinical #RBQMLive2024 #RBQMLIVE #RBQM #ClinicalTrials #ClinicalResearch

Is your approach to clinical trials keeping up with modern demands? Our tip sheet is packed with actionable insights to help you confidently implement RBQM. Don’t miss the tools and tips that could transform your clinical trials. Check it out 👉 https://hubs.ly/Q02PkfWT0 #RBQM #RiskBasedQualityManagement #ClinicalTrials #ClinicalResearch

We are pleased to inform you that Intrinseque Health has successfully achieved its EN ISO 13485:2016 re-certification! This re-certification signifies, Intrinseque Health’s commitment to ‘attention to detail’ while building & executing complex clinical supply plans, which is unparalleled in the clinical supply chain industry. We understand the importance of generating reliable & top-quality data from end-to-end or stand-alone activities, for the projects we undertake. This re-certification is another milestone achieved in our journey of continuous improvement. Our stringent Quality Management System (QMS) is designed to be adaptable to the ever-changing landscape in the clinical supply chain industry. It is a reflection of our commitment to innovation, efficiency, and, most importantly, your satisfaction. Contact us today to discuss how Intrinseque Health can create a robust clinical supply plan for your clinical development programs. [email protected] https://lnkd.in/gPWaDs_n #drugdiscovery #drugdevelopment #studystartup #clinicaltrials #healthcare #clinicalresearch #patientrecruitment #sitemanagement #clinicaldevelopment #clinicaltrial #clinicaloperations #clinicalstudy #clinicalsupply

Best practices in RBQM are influencing clinical study methodology and decentralized trials, putting a spotlight on risk based data review including site and central monitoring. Next week, attend the 4th Risk-Based Quality Management Summit and hear from industry experts on how elements of RBQM can be implemented individually and independently to great success, making clinical trials better, faster, cheaper, and safer for patients. Register now: https://ow.ly/qHgu50QoXrv #DGEvents #RBQMSummit

ISPEP — FUELLED BY INTEGRITY. Who’s in? Integrity in our work as #patientengagement practitioners is the single characteristic that binds us. Wherever you are ‘located’ in patient engagement — patient organization, independent expert, pharma, clinical research, agency, regulator, access specialist, physician — integrity is the indelible characteristic that leads us forward. This is not a competition. Integrity is what you do, how you behave when nobody is looking. It’s your core. Which is why I’m excited to be a founding member of ISPEP — the International Society for Patient Engagement Practitioners. Together with 100 ‘fellows’ we are committed to elevating and sharing standards of professionalism in patient engagement. We will consider the tough challenges in creating professional standards of excellence: we won’t shy from the boundaries that need to be overcome and we will be bold with the questions we need to ask of health organisations, systems and of ourselves. That’s integrity. Please message me if you would like to be added as a member. The formalities and processes will follow shortly but the first step is raising your hand to say ‘I’m in’. I’m in. #patientcentricity #patientvoice #pfmd #patientsfirst #pfdd #patientdriven #patientfocused #shareddecisionmaking #ISPEP