Puja Merchant’s Post

Sharing for my network of leaders in Real World Evidence and Regulatory space.

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Cost reduction in #ClinOps begins with #RBQM! Did you know you can save an average of $2.8M per study? Our Clinical Monitoring Cost Savings Calculator leverages your unique project data to project the potential cost savings achievable through a risk-based strategy in your clinical trials, unlike a conventional non-risk-based approach. Optimize your clinical operations with Cyntegrity's AI-augmented risk-based quality management (#RBQM) portfolio. Our MyRBQM Portal is designed to help you reduce costs while enhancing predictability and compliance in your clinical studies. Ready to enhance your clinical trials and save big on monitoring expenses? Request a demo for our MyRBQM Portal today. #ClinicalOperations #ClinicalTrials #ClinicalResearch #ClinicalMonitoring

🔜 The Veeva Systems R&D and Quality Summit is almost here! 📆 4 - 5 June 📍 Madrid 🇪🇸 🎬 Watch the short video to hear more about the Safety Zone at this year's #VeevaSummitEU and sneak peak on the agenda. Here are the top 3 reasons why you should attend: 1️⃣ Discover ways to rapidly modernise and automate key pharmacovigilance processes; 2️⃣ See how safety organisations easily collaborate cross-functionally and with external partners; and 3️⃣ Connect with safety leaders and peers to exchange best practices for advancing patient safety. ✅ Register now - Link in the comments below 👇🏻 🎤 Are you going? Share what you're looking forward to!

Attention #ClinOps Managers! Are you looking to manage your clinical trial data beyond traditional Excel methods? Explore advanced cost reduction methods with our Clinical Monitoring Cost Savings Calculator. Designed for decision-makers like you, this tool uses your specific project data to estimate potential cost savings that a risk-based strategy could offer compared to a traditional approach. Our #AI-augmented risk-based quality management (#RBQM) allows you to strategically allocate your resources, reduce unnecessary visits, and achieve significant cost savings. From risk management to operational efficiency, compliance boost, source data verification (#SDV) savings, optimized visit schedule, and protocol amendment reduction, our RBQM strategy covers all areas of cost savings. Ready to enhance your clinical trials and save big on monitoring expenses? Request a demo for our MyRBQM Portal today. #OperationalEfficiency #CostSavings #ClinicalOperations #ClinicalOperationsManager #ClinicalTrials #ClinicalResearch #ClinicalMonitoring

Dive into the world of Clinical Trial Management with our latest video of the week: "QA and Audits: Key Components of Clinical Trial Management." 🌟 Whether you're a seasoned professional or just starting out, this video is packed with valuable insights. Don't miss out - click the link to watch now! https://zurl.co/8o9H #ClinicalTrials #QualityAssurance #Audits

Let’s play a quick game of true or false. First question: true or false—a TMF is the responsibility of the clinical development team? Take a moment to think about it... If you answered “false,” you’re correct. TMFs are not just for clinical teams! Sites, pharmacovigilance, CROs, and other teams all need to produce documentation to maintain the TMF. The problem comes when TMF completeness becomes a burden on one group, rather than everyone involved in contributing to the TMF. In the same vein, I recently read something that was pretty surprising to me; Respondents to Montrium’s 2023 State of TMF Industry Survey overwhelmingly reported that an incomplete TMF is their biggest challenge to inspection readiness. And what is the best indicator of TMF completeness? I believe that it is complete alignment. I know how difficult it can be to achieve stakeholder alignment, especially when some of the stakeholders don’t believe they need to be involved. But, if I can give you one piece of advice, it’s this: align everyone from the very beginning. Alignment starts when the clinical trial story starts, and no later. Be sure that everyone knows their role, what they need to contribute, and how they need to work to maintain quality and data integrity . In order to improve our TMF metrics, we need to improve our approach to TMF culture. How does your organization work to improve TMF culture? I’d love to hear from you in the comments! And be sure to check out the Resource Center on the Montrium website to read the full State of TMF report for yourself!

The clinical trial regulatory inspection—among the most pivotal steps in reaching approval—is going through an evolution. Regulatory authorities across the globe are updating their requirements to keep up with new eClinical technology, the increasing complexities of clinical trials, and a new, unexpected variable: COVID-19. As the pandemic has made on-site inspections challenging across most of the world, remote inspections have become vital to keeping studies moving forward. How does this change the way we prepare for inspections, and how do we address the new challenges a remote inspection could bring? Your eTMF—like a paper one—tells your study’s story. It needs to contain any documentation, data, and metadata required to conduct your study. This is why it’s so important to make sure your eTMF is inspection ready. Can you find all of your documents in a quick, easy format? If you have documents in a different system, is that noted? Is everything filed correctly and quality checked? Make sure you can answer these questions. It’s also important to have all of your stakeholders review the content they own. In fact, it’s best to push your stakeholders to review and update content on an ongoing basis to keep a contemporaneous TMF. Work with your stakeholders to make sure they submit their documents on time. Create an SOP with tangible dates and timelines that are reasonable. Hold people to your study goals and timelines with documented guidelines. #TMF #eTMF #clinicaltrials #bestpractices #clinicalresearch https://lnkd.in/exKB4Pk6