In life sciences, CMC data holds more power than we realize. When managed strategically, it can accelerate innovation, ensure compliance, and improve decision-making across the product lifecycle. Our latest blog dives into how a master data–led approach can turn complex CMC data into a true business advantage. Read the full blog here https://lnkd.in/geXSS6BT Preeti Irny Desai Colin Wood #LifeSciences #CMC #DataStrategy #PharmaInnovation #MasterData
How CMC Data Can Boost Life Sciences Innovation
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What if data is the return on investment in a life sciences meeting? Data is often seen as something that can demonstrate ROI (and it is!), but the right data can also be one of the best things you get from a meeting. This article highlights how to leverage meeting metrics to gain information to guide future training, improve drug development, and help with strategic decision-making. https://hubs.ly/Q03LVly40 #lifesciences #meetingmetrics #investigatormeetings #CME
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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
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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
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Is your R&D data growing faster than you can make sense of it? Discover how to turn that challenge into an advantage: https://lnkd.in/gY2K6zZk In biopharma, vast amounts of data often end up fragmented slowing discovery, delaying approvals, and hiding millions in lost value. That’s where FAIR - Findable, Accessible, Interoperable, and Reusable, comes in. It’s not an instant fix but a long-term transformation. In this whitepaper, Excelra shares two decades of experience helping organizations turn raw data into a strategic asset for AI-driven R&D. FAIR adoption has: • Cut re-submission cycles by 25% • Improved data findability by 40% • Reduced duplicate experiments by 25% • Fueled 15+ publications Download the whitepaper to see how Excelra operationalizes FAIR and future-proofs R&D data ecosystems. #Biopharma #LifeSciences #DrugDiscovery #PharmaR&D #FAIRData #Excelra #DataDrivenResearch #AIinPharma #R&DInnovation Poulami Chatterjee
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Consistency, speed, confidence. Biogen unlocked all three with Certara’s clinical metadata repository (CMDR) and CRFs platform. Managing CDISC standards across 100+ studies required more than just spreadsheets. With 𝗖𝗲𝗿𝘁𝗮𝗿𝗮’𝘀 𝗣𝗶𝗻𝗻𝗮𝗰𝗹𝗲 𝟮𝟭 𝗘𝗻𝘁𝗲𝗿𝗽𝗿𝗶𝘀𝗲, Biogen achieved: ✅ Increased reuse rates ✅ Conformance with CDISC standards ✅ Smooth transition from ADaMIG v1.1 to v1.3 As Todd Bazin, Head, Data Standards at Biogen, said: "𝘛𝘩𝘦 𝘱𝘭𝘢𝘵𝘧𝘰𝘳𝘮 𝘪𝘴 𝘰𝘶𝘳 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘢𝘵𝘪𝘷𝘦 𝘴𝘰𝘶𝘳𝘤𝘦 𝘧𝘰𝘳 𝘮𝘦𝘵𝘢𝘥𝘢𝘵𝘢. 𝘞𝘦 𝘥𝘦𝘷𝘦𝘭𝘰𝘱 𝘢𝘯𝘥 𝘮𝘢𝘪𝘯𝘵𝘢𝘪𝘯 𝘤𝘰𝘯𝘵𝘦𝘯𝘵 𝘴𝘰 𝘸𝘦 𝘤𝘢𝘯 𝘦𝘯𝘴𝘶𝘳𝘦 𝘵𝘩𝘢𝘵 𝘰𝘶𝘳 𝘨𝘭𝘰𝘣𝘢𝘭 𝘭𝘪𝘣𝘳𝘢𝘳𝘺 𝘢𝘤𝘤𝘶𝘳𝘢𝘵𝘦𝘭𝘺 𝘳𝘦𝘧𝘭𝘦𝘤𝘵𝘴 𝘰𝘶𝘳 𝘴𝘵𝘢𝘯𝘥𝘢𝘳𝘥𝘴. 𝘞𝘦'𝘷𝘦 𝘩𝘢𝘥 𝘢 𝘭𝘰𝘵 𝘰𝘧 𝘨𝘳𝘦𝘢𝘵 𝘴𝘶𝘱𝘱𝘰𝘳𝘵 𝘧𝘳𝘰𝘮 𝘊𝘦𝘳𝘵𝘢𝘳𝘢’𝘴 𝘵𝘦𝘢𝘮." 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗰𝗮𝘀𝗲 𝘀𝘁𝘂𝗱𝘆: https://ow.ly/3eHy50X0kah #Certara #Pinnacle21 #MetadataManagement #DataStandards
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The vision of seamless, standards-driven data flow in clinical trials has always felt just out of reach. Instead, we make do with fragmented systems, manual handoffs and legacy processes. That’s changing quickly. We’re closer than ever to achieving “data at the speed of light,” thanks to four major shifts: - Rich, diverse data - Maturing technology - Evolving regulatory pathways - Industry alignment around shared standards GSK’s Sam Warden and my colleague Sowmyanarayan Srinivasan will talk about this on October 28, as they explore what data at the speed of light will mean for clinical development. It’s a great opportunity to hear examples of companies connecting trial data from the source all the way through submission. You can register for the webinar here: https://lnkd.in/dbGbRT3v
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Having to repeat analyses due to data volatility in real-world claims data can cost you 2-4 days, sometimes 10 or more. Who has time for that? We surveyed U.S. biopharma leaders to understand the ways data volatility impacts them. Find out how unreliable source data can affect referral analysis, sales attribution, market sizing, and much more. Download - How Claims Data Volatility is Impacting Biopharma: A 2025 Industry Snapshot 👉 https://lnkd.in/gbMFRhNe #DataStrategy #HealthData #LifeSciences #RWD #RealWorldData
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In biotech labs, data lives in the LIMS Conversations often live everywhere else That disconnect slows down projects and creates confusion. That’s why we help biotech teams build Contextual Chat inside the LIMS - a dedicated discussion space for every sample, project, protocol or material. ✅ Notes and updates stay with the data ✅ Attachments and results never get lost ✅ Approvals and pinned messages are always traceable ✅ Mentions and notifications keep the right people in the loop Fewer errors and clearer accountability. This is how we help our biotech clients reduce daily friction - so they can focus on what matters most: the science. We break it down in our latest article in the series “Custom LIMS Features for Hidden Lab Pains” Read here: https://lnkd.in/djevp5Z3
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Managing CDASH, SDTM, and ADaM standards across 100+ global studies is no easy job. When Biogen brought clinical data management in-house, spreadsheets just couldn’t keep up. That’s when they turned to Certara’s Pinnacle 21 Enterprise platform with a 𝗰𝗲𝗻𝘁𝗿𝗮𝗹𝗶𝘇𝗲𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗺𝗲𝘁𝗮𝗱𝗮𝘁𝗮 𝗿𝗲𝗽𝗼𝘀𝗶𝘁𝗼𝗿𝘆 (𝗖𝗠𝗗𝗥). The shift paid off and Biogen achieved: - Higher reuse rates - Faster standards transitions (including ADaMIG v1.1 to v1.3) - Smoother study builds in their Rave EDC system As Todd Bazin, Head, Data Standards at Biogen, shared: "𝘛𝘩𝘦 𝘱𝘭𝘢𝘵𝘧𝘰𝘳𝘮 𝘪𝘴 𝘰𝘶𝘳 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘢𝘵𝘪𝘷𝘦 𝘴𝘰𝘶𝘳𝘤𝘦 𝘧𝘰𝘳 𝘮𝘦𝘵𝘢𝘥𝘢𝘵𝘢. 𝘞𝘦 𝘥𝘦𝘷𝘦𝘭𝘰𝘱 𝘢𝘯𝘥 𝘮𝘢𝘪𝘯𝘵𝘢𝘪𝘯 𝘤𝘰𝘯𝘵𝘦𝘯𝘵 𝘴𝘰 𝘸𝘦 𝘤𝘢𝘯 𝘦𝘯𝘴𝘶𝘳𝘦 𝘵𝘩𝘢𝘵 𝘰𝘶𝘳 𝘨𝘭𝘰𝘣𝘢𝘭 𝘭𝘪𝘣𝘳𝘢𝘳𝘺 𝘢𝘤𝘤𝘶𝘳𝘢𝘵𝘦𝘭𝘺 𝘳𝘦𝘧𝘭𝘦𝘤𝘵𝘴 𝘰𝘶𝘳 𝘴𝘵𝘢𝘯𝘥𝘢𝘳𝘥𝘴. 𝘞𝘦'𝘷𝘦 𝘩𝘢𝘥 𝘢 𝘭𝘰𝘵 𝘰𝘧 𝘨𝘳𝘦𝘢𝘵 𝘴𝘶𝘱𝘱𝘰𝘳𝘵 𝘧𝘳𝘰𝘮 𝘊𝘦𝘳𝘵𝘢𝘳𝘢'𝘴 𝘵𝘦𝘢𝘮." Read the full case study: https://ow.ly/3eHy50X0kah #Certara #Pinnacle21 #MetadataManagement #DataStandards
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[𝘾𝘼𝙎𝙀 𝙎𝙏𝙐𝘿𝙔] From Data Overload to Business Strategy: A Biotech Case Study on Actionable Insights Watch this session to see how a leading biotech company used Quillit by Civicom Marketing Research Services to turn data overload into real-time consumer insights for faster decisions. https://lnkd.in/ewbRxpft
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1wSpot on. Strategic CMC data management is where speed and quality actually meet.