How to achieve 'data at the speed of light' in clinical trials

How Smarter Clinical Data Management Accelerates Drug Development In one recent trial, a life sciences team reduced data query turnaround time by 40% just by integrating an AI-powered Clinical Data Management system. 📊 Instead of manually reconciling site data, lab results, and EDC entries, the platform automated validation, flagged inconsistencies in real-time, and provided data managers with actionable insights. The result? ✅ Faster database lock ✅ Higher data accuracy ✅ Earlier insights for patient safety and efficacy This isn’t just data management — it’s *data intelligence*. And it’s redefining how we deliver safe, effective therapies faster to those who need them most. #ClinicalDataManagement #LifeSciences #ClinicalTrials #DataQuality #HealthTech #DigitalTransformation #PharmaInnovation #AIinHealthcare

Join IQVIA Laboratories’ Gavin Hershaw at SCOPE Europe! Gavin will be presenting on how central lab electronic data capture (EDC) innovation is elevating site engagement and data integrity — featuring a case study with Lilly. He will explore how evolving approaches to EDC are enhancing accuracy, efficiency, and the site user experience in today’s clinical trials. Discover how smarter data strategies are shaping the future of clinical research. Learn more: https://bit.ly/4h3iz2j #SCOPEEurope

Join IQVIA Laboratories’ Gavin Hershaw at SCOPE Europe! Gavin will be presenting on how central lab electronic data capture (EDC) innovation is elevating site engagement and data integrity — featuring a case study with Lilly. He will explore how evolving approaches to EDC are enhancing accuracy, efficiency, and the site user experience in today’s clinical trials. Discover how smarter data strategies are shaping the future of clinical research. Learn more: https://bit.ly/4h3iz2j #SCOPEEurope

🤔 I’ve been reflecting on the FDA’s recent move to daily FAERS reporting and what it truly means for our industry. One phrase in the announcement stood out to me: “...𝙧𝙚𝙖𝙡-𝙩𝙞𝙢𝙚 𝙥𝙧𝙤𝙩𝙚𝙘𝙩𝙞𝙤𝙣 𝙤𝙛 𝙥𝙪𝙗𝙡𝙞𝙘 𝙝𝙚𝙖𝙡𝙩𝙝.” There’s no doubt this is a big step forward in transparency. Yet let’s be clear: 𝘁𝗵𝗶𝘀 𝗶𝘀 𝗮𝗻 𝗲𝗻𝗮𝗯𝗹𝗲𝗿, 𝗻𝗼𝘁 𝘁𝗵𝗲 𝗲𝗻𝗱𝗽𝗼𝗶𝗻𝘁. ⚠️ The data still has long-standing limitations: 𝗥𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴 𝗯𝗶𝗮𝘀: underreporting, selective reporting, and delays in submission 𝗗𝘂𝗽𝗹𝗶𝗰𝗮𝘁𝗲𝘀 𝗮𝗻𝗱 𝗶𝗻𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗿𝗲𝗽𝗼𝗿𝘁𝘀 𝗖𝗮𝘂𝘀𝗮𝗹𝗶𝘁𝘆 𝗻𝗼𝘁 𝗰𝗼𝗻𝗳𝗶𝗿𝗺𝗲𝗱 — FAERS captures suspicions, not proof 𝗡𝗼𝗶𝘀𝗲-𝘁𝗼-𝘀𝗶𝗴𝗻𝗮𝗹 — daily unfiltered data may overwhelm without analytics 𝗣𝗶𝗽𝗲𝗹𝗶𝗻𝗲 𝗹𝗮𝘁𝗲𝗻𝗰𝘆 — faster publishing doesn’t guarantee timely entry The only thing that has changed is ...this data is now available daily. :) 🏢 𝗪𝗵𝗮𝘁 𝗶𝘁 𝗺𝗲𝗮𝗻𝘀 𝗳𝗼𝗿 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗣𝗵𝗮𝗿𝗺𝗮 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀: PV and regulatory teams must rethink how to use this data. That could mean continuous monitoring, upgraded triage, and stronger communication strategies. Advanced methods — disproportionality, Bayesian models, machine learning — will need to adapt to daily flows. 𝗩𝗲𝗻𝗱𝗼𝗿𝘀 & 𝗔𝗜 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗲𝗿𝘀: A clear opportunity to build tools that can scale, filter noise, and deliver earlier, more meaningful insights. 💡 𝗕𝗼𝘁𝘁𝗼𝗺 𝗹𝗶𝗻𝗲: Daily FAERS reporting reduces access delays, but its true impact will depend on how effectively stakeholders decide to use this daily data. Thoughts? #𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 #𝗗𝗿𝘂𝗴𝗦𝗮𝗳𝗲𝘁𝘆 #𝗙𝗗𝗔 #𝗙𝗔𝗘𝗥𝗦 #𝗥𝗲𝗮𝗹𝗧𝗶𝗺𝗲𝗗𝗮𝘁𝗮 #𝗣𝗵𝗮𝗿𝗺𝗮𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻

Ever wonder what it takes to get a new drug approved? 🤔 It all comes down to the data. I've put together a presentation that breaks down the entire clinical trial process, with a special focus on the indispensable role of the Statistical Programmer. Check out how these professionals turn raw data into the insights that drive life-saving decisions. #DrugDevelopment #ClinicalTrials #DataAnalytics #StatisticalProgrammer #Biostatistics #Healthcare

Biogen is rethinking the way its study metadata is managed, boosting efficiency and collaboration with our Clinical Metadata Repository. Explore the full story here: https://ow.ly/1nhy50X2rmG #ClinicalTrials #ClinicalMetadataManagement #Certara

Clinical metadata management is the backbone of reliable drug development. But when Biogen brought data management in-house, manual processes for CDASH, SDTM, and ADaM were slowing their 100+ global studies. Certara’s Pinnacle 21 Enterprise platform changed that. With an intuitive interface and seamless 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲𝗶𝗿 𝗥𝗮𝘃𝗲 𝗘𝗗𝗖 𝘀𝘆𝘀𝘁𝗲𝗺, Biogen transformed how they manage metadata, boosting efficiency and scalability. As Todd Bazin, Head, Data Standards at Biogen, explains: "𝘛𝘩𝘦 𝘶𝘴𝘦𝘳 𝘪𝘯𝘵𝘦𝘳𝘧𝘢𝘤𝘦 𝘰𝘧𝘧𝘦𝘳𝘦𝘥 𝘢𝘥𝘷𝘢𝘯𝘵𝘢𝘨𝘦𝘴, 𝘢𝘯𝘥 𝘪𝘵 𝘸𝘢𝘴 𝘧𝘶𝘯 𝘵𝘰 𝘸𝘰𝘳𝘬 𝘸𝘪𝘵𝘩. 𝘠𝘰𝘶 𝘤𝘢𝘯 𝘣𝘶𝘪𝘭𝘥 𝘵𝘩𝘦 𝘧𝘰𝘳𝘮𝘴 𝘢𝘯𝘥 𝘤𝘳𝘦𝘢𝘵𝘦 𝘷𝘪𝘴𝘶𝘢𝘭𝘪𝘻𝘢𝘵𝘪𝘰𝘯𝘴 𝘰𝘧 𝘸𝘩𝘢𝘵 𝘺𝘰𝘶'𝘷𝘦 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘦𝘥, 𝘵𝘰 𝘧𝘢𝘤𝘪𝘭𝘪𝘵𝘢𝘵𝘦 𝘴𝘵𝘢𝘬𝘦𝘩𝘰𝘭𝘥𝘦𝘳 𝘳𝘦𝘷𝘪𝘦𝘸𝘴 𝘦𝘢𝘳𝘭𝘺 𝘰𝘯." 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗰𝗮𝘀𝗲 𝘀𝘁𝘂𝗱𝘆 𝗵𝗲𝗿𝗲: https://ow.ly/3eHy50X0kah #Certara #Pinnacle21 #MetadataManagement #DataStandards

Less manual work. More decision-ready insights. 💬 “I’m one of the biggest advocates for Within3… it’s so much less I have to do.” In complex, competitive markets, #pharma success hinges on clarity, speed, and decisive action. Within3 brings together your most critical data sources into one real-time view — so teams can align faster, adapt instantly, and act with confidence. Learn more about turning your data into decision-ready insights: https://hubs.la/Q03KsL8r0 #data #lifesciences #launchexcellence #pharmalaunch #medicalaffairs

The articles referenced below show how real-world evidence (RWE) is moving from concept to practice on multiple fronts. FDA’s updated compendium now includes dozens of cases where RWE supported approvals, safety decisions, and labeling changes — a valuable benchmark for anyone planning regulatory submissions. In Europe, DARWIN EU continues to expand its federated network, giving regulators the ability to run pan-European studies directly across national datasets. On the industry side, the deal pace remains brisk: PE firms are actively consolidating data-rich platforms, while companies like Innovaccer are acquiring to deepen their specialty-care and outcomes capabilities. The common thread is clear: organizations that combine large-scale, interoperable data assets with rigorous methodological standards are best positioned to drive both regulatory confidence and market value in the next phase of evidence generation. Sources: 1. FDA: Use of Real-World Evidence in Regulatory Decision Making – link 2. EMA: DARWIN EU – link 3. Innovaccer Acquires Story Health – link 4. WSJ: Healthtech Consolidation Surge – link

💸 The Hidden Costs of Inefficient Clinical Trials — And How to Fix Them Here’s something I’ve learned working with biopharma teams: the real cost of a clinical trial isn’t always what shows up on the budget sheet. Every delayed patient enrollment, every protocol amendment, every data silo creates hidden costs: * promising therapies that take years longer to reach patients, * teams burning time chasing reports instead of insights, * investors losing confidence when timelines slip. It adds up to billions across the industry. The fix isn’t just “work harder” or “hire more people.” It’s rethinking how trials are designed and run: ✅ smarter patient matching with real-world data ✅ adaptive trial designs powered by predictive models ✅ interoperable platforms so teams can actually collaborate instead of wrestling with spreadsheets At Tag.bio, we’ve seen how connecting the right data with the right people at the right time can shave months off timelines. The question I’d love to ask: where do you see the biggest hidden costs in trials today — and what’s one thing you’d change to fix it? #ClinicalTrials #Biopharma #DrugDevelopment #DataScience