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Processes and technology are nothing without people. In TMF management, you need to consider all 3. Steal our cheat sheet to design a TMF training strategy with your people in mind. #TMF #eTMF #ClinicalTrials #ClinicalResearch

Like a human body, a clinical trial is a complex organism in which many systems must work together to ensure that everything runs smoothly and effectively. 💪⚙️   A risk-based quality management (RBQM) framework helps to organize and unify trials, supplying the flexibility, adaptability, and rapid data-driven decision-making you need to optimize your research process.   Follow @Medidata-Solutions and download our eBook to discover more: https://mdso.io/w5g    #DataQuality #ClinicalDataStudio #Medidata

🔔 Poll Results & Key Insights: E8(R1) & E6(R3) Updates Last week, we asked you a challenging question in our poll: What are the items new in E8(R1) AND expected to be added to E6(R3)? 🖋 Here’s how you responded: - Fit for Purpose: 14% - Risk-Based Quality Management (RBQM): 48% - Quality Culture: 3% - Options 1 and 3 (Fit for Purpose + Quality Culture): 34%  🔍 The correct answer? Options 1 and 3 – "Fit for Purpose" and "Quality Culture". These two elements are new in E8(R1) and are expected to be incorporated into E6(R3). Let’s break it down:  1️⃣ Fit for Purpose: Not a brand-new concept, but crucial nonetheless. This principle emphasizes that products, services, or data should meet stakeholder expectations—whether it’s study sponsors, regulators, medical personnel, or patients. In the clinical research context, “Fit for Purpose” is a cornerstone of both E8(R1) and E6(R3), ensuring that the quality of information generated supports sound decision-making while protecting participants. 2️⃣  Quality Culture: This concept revolves around fostering an environment where quality is a fundamental priority. E8(R1) encourages creating a culture that values critical thinking and open dialogue, moving beyond just tools and checklists. E6(R3) builds on this by integrating quality into every aspect of trial design and development, ensuring a proportionate, risk-based approach.  ⁉ Why not RBQM? Stay tuned for next week’s poll where we’ll dive into why "RBQM" didn’t make the cut as the correct answer this time. Keep engaging with us for more insights and updates! #ClinicalTrials #QualityCulture #GCP #ClinicalResearch #RBQM #Quality #e6r3 #e8r1 #QualityAssurance

The future of TMF management is risk-based. 🚀 Modern clinical trials are growing increasingly complex—including more diverse populations, intricate protocols, and rapidly advancing technologies. And modern clinical trials deserve a modern approach. Enter risk based TMF management. It’s an approach that empowers TMF teams to adapt to the modern clinical trial landscape while focusing on: ✅ improving trial quality, 🦺 participant safety, 📈 and data integrity. To help you get started implementing a risk-based approach to TMF management, our experts Donatella Ballerini and Paul Fenton co-authored our latest whitepaper: Building a Risk-Based TMF Management Framework. 📝 It’s going to be your go-to guide for setting up a risk-based TMF approach that is tailor-made for your organization’s needs. Visit the link in the comments to download the full resource. 👇 #TMF #eTMF #ClinicalResearch #ClinicalTrials

RBQM Essentials – Green Belt e-course is now live! Shorten the distance to your professional success: completed in less than 6 hours, it offers a unique, in-depth view of risk-based quality management methodology. Perfect for clinical research professionals. Don't miss out on our introduction offer (valid until April 4): https://lnkd.in/eSB9yzkD Our Green Belt e-course is based on real-world clinical study data, making it a unique learning experience for clinical research professionals leading clinical trials or serving as study team members. With this real-world data approach, you’ll excel in risk detection, evaluation, control, communication, review, and reporting, in line with ICH Good Clinical Practice E6(R2) in less than 6 hours. #ClinicalResearch #RiskBasedQualityManagement #RBQM #ClinicalTrials

Every change starts with a good understanding of a goal and reasons. RBQM is NOT an exception. It is not a simple transformation for a company. However, it has the best potential of saving unneeded costs and improving your chances of success in clinical research. Learn from the best WHY and HOW: Johann Proeve, Keith Dorricott

At QRCC, we pride ourselves on turning challenges into success stories. Recently, we helped a client navigate complex regulatory hurdles, ensuring their trial moved forward smoothly and efficiently. Our tailored consultancy services and strategic problem-solving approach added immense value to their project. With QRCC, you don’t just get a consultant—you gain a partner dedicated to helping you achieve your goals. Contact us today to learn how we can support your clinical research needs. #SuccessStory #ClinicalConsultancy #ProblemSolving #ProjectManagement

📢 Check out this article from the IHS Accreditation Insider Newsletter! 📢 🔍 Read about a recent update on accreditation interpretation changes: When it comes to preparing meeting minutes for committees like the Quality Management Committee or Clinical Oversight Body, precision is key. Accurately documenting the approval of policies, procedures, program documents, and the review and analysis of various metrics and materials such as literature and risk assessments is crucial. And here's a pro tip: if any documents undergo review, analysis, and approval during the meeting, it's highly recommended to attach them to the meeting minutes. 💡 Why attach them, you ask? Well, including a PDF or attachment of the reviewed and approved document(s) provides accreditation reviewers with visibility into the materials discussed during the meeting. This not only ensures transparency but also enhances the understanding of the decision-making process. Stay tuned for more insightful updates from the IHS Accreditation Insider Newsletter, your ultimate source for staying up to date with accreditation interpretation updates and best practices! 🌟 #AccreditationInsider #IHSNewsletter #MeetingMinutes #AccreditationBestPractices #URAC Link to the IHS Accreditation Insider newsletters: https://lnkd.in/ev4h3udj

Did you know WCG is more than an IRB? When you leverage our leading study review solutions, you can communicate with a single point of contact, access the largest network of global experts, and ultimately save time in your study reviews. We utilize cutting-edge technologies to accelerate your Study Review with our suite of Review Solutions: 🔍IRB Review 🔍IBC Review 🔍Endpoint Adjudication Committee 🔍Data Monitoring Committee Discover how WCG Review Solutions can accelerate your #clinicaltrial. Learn more at https://lnkd.in/e2cPg-Hv #IRB #IBC EAC #DMC #studyreview #clinicalresearch #WCG

😴 Tired of outdated quality management models? It's time to break free! Learn how RBQM can supercharge your clinical trials with smarter insights. 📈 Curious? Our comprehensive guide offers: 🔍 Essential insights and strategies 📈 Proven best practices for complex applications 🛠️A framework for successful implementation Watch the video and unlock the full #RBQM Guide here: https://hubs.ly/Q02DjRj10 #RBQM #ClinicalTrials #QualityManagement #ClinicalResearch