How AI transformed clinical trial protocols for a biopharma company

Discover what’s shaping the future of pharma. Norstella’s monthly roundup brings you expert insights, brand highlights, and the latest industry breakthroughs. Watch the video and explore the full roundup below. 👇 Real-world data holds immense potential, yet most manufacturers are only beginning to tap into it. Norstella’s white paper, “Real-World Data in 2025 and Beyond: Closing the Strategy Gap,” explores what’s holding pharma back—and how to move forward. Download the white paper: https://vist.ly/4emcp Citeline breaks down how ICH GCP E6(R3) is reshaping clinical trials—moving from checklists to clear mandates. Sponsors must act on quality, risk, and transparency. Download the white paper: https://vist.ly/4emcs Pharma is changing fast. Biotech’s lean models and direct-to-consumer moves are shaking up the old rules. Patients have more power, and delivery innovations are driving billion-dollar deals. Want to know what’s next? Dive into Evaluate Ltd’s latest insights on modular biopharma, royalty financing, and consumer-led innovation. Access the report: https://vist.ly/4emcq Employee Spotlight! Meet Bryan O. Nieves, MBA, a member of MMIT (Managed Markets Insight & Technology)’s sales team who joined the company after spending 12 years in the EMR space, working with post-acute organizations. He particularly enjoys deals that use the vast power of unstructured EMR data to benefit clients. Learn more: https://vist.ly/4emcr For rare disease patients, every moment matters—but diagnosis delays can span years. Panalgo is helping life sciences teams accelerate answers by combining unstructured data with NLP analytics. Learn more: https://vist.ly/4emcn Skipta’s “PA Unite” Micro-Community gives brands exclusive access to over 108,000 verified PAs—right where they engage daily. With targeted visibility and reduced competition, Skipta helps you deliver educational and brand content at the right time. Learn more: https://vist.ly/4emct Follow our brands to stay updated with the latest news and insights. #Norstella #Pipeline2Patient #FollowNorstella

One area I have been poking around within pharmatech is persona generation. A new class of persona-driven systems are being built to model the incentives, language, and workflows of specific stakeholders in the ecosystem, whether it is physicians, regulators, patients or payers. Instead of generic text generation, new models simulate how each persona interprets data, reacts to messaging, and makes decisions. The result would be better trial designs, more persuasive regulatory narratives, and targeted (and compliant) patient engagement strategies. Think of it as the shift from generating content to generating context. As I think about defensibility in this space, it will likely come from domain-specific data + workflow integration. The moat isn’t the LLM, but rather the persona graph that mirrors the real-world decision stack of biopharma.

Discover what’s shaping the future of pharma. Norstella’s monthly roundup brings you expert insights, brand highlights, and the latest industry breakthroughs. Watch the video and explore the full roundup below. 👇 Real-world data holds immense potential, yet most manufacturers are only beginning to tap into it. Norstella’s white paper, “Real-World Data in 2025 and Beyond: Closing the Strategy Gap,” explores what’s holding pharma back—and how to move forward. Download the white paper: https://vist.ly/4dnbg Citeline breaks down how ICH GCP E6(R3) is reshaping clinical trials—moving from checklists to clear mandates. Sponsors must act on quality, risk, and transparency. Download the white paper: https://vist.ly/4dnbj Pharma is changing fast. Biotech’s lean models and direct-to-consumer moves are shaking up the old rules. Patients have more power, and delivery innovations are driving billion-dollar deals. Want to know what’s next? Dive into Evaluate Ltd’s latest insights on modular biopharma, royalty financing, and consumer-led innovation. Access the report: https://vist.ly/4dnbh Employee Spotlight! Meet Bryan O. Nieves, MBA, a member of MMIT (Managed Markets Insight & Technology)’s sales team who joined the company after spending 12 years in the EMR space, working with post-acute organizations. He particularly enjoys deals that use the vast power of unstructured EMR data to benefit clients. Learn more: https://vist.ly/4dnbi For rare disease patients, every moment matters—but diagnosis delays can span years. Panalgo is helping life sciences teams accelerate answers by combining unstructured data with NLP analytics. Learn more: https://vist.ly/4dnbf Skipta’s “PA Unite” Micro-Community gives brands exclusive access to over 108,000 verified PAs—right where they engage daily. With targeted visibility and reduced competition, Skipta helps you deliver educational and brand content at the right time. Learn more: https://vist.ly/4dnbk Follow our brands to stay updated with the latest news and insights. #Norstella #Pipeline2Patient #FollowNorstella

Discover what’s shaping the future of pharma. Norstella’s monthly roundup brings you expert insights, brand highlights, and the latest industry breakthroughs. Watch the video and explore the full roundup below. 👇 Real-world data holds immense potential, yet most manufacturers are only beginning to tap into it. Norstella’s white paper, “Real-World Data in 2025 and Beyond: Closing the Strategy Gap,” explores what’s holding pharma back—and how to move forward. Download the white paper: https://vist.ly/4cu5r Citeline breaks down how ICH GCP E6(R3) is reshaping clinical trials—moving from checklists to clear mandates. Sponsors must act on quality, risk, and transparency. Download the white paper: https://vist.ly/4cu5u Pharma is changing fast. Biotech’s lean models and direct-to-consumer moves are shaking up the old rules. Patients have more power, and delivery innovations are driving billion-dollar deals. Want to know what’s next? Dive into Evaluate Ltd’s latest insights on modular biopharma, royalty financing, and consumer-led innovation. Access the report: https://vist.ly/4cu5s Employee Spotlight! Meet Bryan O. Nieves, MBA, a member of MMIT (Managed Markets Insight & Technology)’s sales team who joined the company after spending 12 years in the EMR space, working with post-acute organizations. He particularly enjoys deals that use the vast power of unstructured EMR data to benefit clients. Learn more: https://vist.ly/4cu5t For rare disease patients, every moment matters—but diagnosis delays can span years. Panalgo is helping life sciences teams accelerate answers by combining unstructured data with NLP analytics. Learn more: https://vist.ly/4cu5q Skipta’s “PA Unite” Micro-Community gives brands exclusive access to over 108,000 verified PAs—right where they engage daily. With targeted visibility and reduced competition, Skipta helps you deliver educational and brand content at the right time. Learn more: https://vist.ly/4cu5v Follow our brands to stay updated with the latest news and insights. #Norstella #Pipeline2Patient #FollowNorstella

🔍 The Hidden Cost of Manual Reconciliation Every clinical study generates thousands of samples, PDFs, and lab reports — each with its own timelines, identifiers, and test results. Yet even today, many translational and clinical ops teams still reconcile them by hand — stitching spreadsheets, cross-checking lab uploads, and chasing missing results. The result? Weeks of delay, high error risk, and limited visibility. That’s why we built SpeciGen — an AI-driven platform that automates the messy middle of biospecimen operations. ✅ Reconcile thousands of samples in minutes, not weeks ✅ Track results and upload large files (including SVS image data) ✅ Automatically scan PDFs to extract biomarker and lab test results ✅ Detect anomalies early with AI-guided insights ✅ Maintain an auditable, protocol-aligned record across sites, vendors, & labs SpeciGen turns scattered sample data into structured, searchable insights — so teams can focus on science, not spreadsheets. 👉 Learn more: specigen.ai #ClinicalTrials #TranslationalResearch #Biospecimens #DataIntegrity #AIinLifeSciences #Biomarkers #ClinicalData #SpeciGen

Site selection remains one of the biggest bottlenecks in the clinical trial industry. But what if you had a digital replica of every research site, continuously updated with performance metrics, operational data, and regional insights? That's exactly what AI Site Twins deliver. The technology that powered breakthroughs in drug discovery is now available for clinical operations. Read our free guide to see how this technology is reshaping clinical trials. 🔗 https://lnkd.in/gFJenGV4 #ClinicalTrials #AIdrugdevelopment #AIinPharma #HealthcareAI #DigitalTwins

The fact that clinical trials still take 8-12 years and can cost over $2 billion, even with today's AI advancements, is devastating for patients. Our mission at Ryght AI is to streamline the costly, lengthy, and very manual process of site selection and activation. We aren't "just another tool" to add to your tech stack, we are the only end-to-end platform that will ingest and harmonize your proprietary data that is SOC 2 & HIPAA compliant. We help our partners make data-driven site decisions, co-develop tools to automate any manual workflows, and even connect to CTMS/E Source data to monitor/remediate sites in real time. We also offer your selected sites powerful AI tools to help with patient pre-screening, visit planning and more! It's time for the industry to step out of its comfort zone by solely relying on past relationships and a narrow focus. Imagine having insights at your fingertips to competing studies at the site, PI experience, trial experience, past enrollment rates, and even equipment at the facility. We have that and are ready to help you shave months off your timelines by doing it the Ryght way.

Pharma is one of the most data-rich industries in the world yet much of its intelligence never gets used. Field reps capture thousands of touchpoints every day: doctor conversations, event insights, follow-up notes. But that data often stays buried in disconnected systems, scattered CRMs, or delayed reports. The result? Missed trends. Slower reactions. Decisions made without full context. That’s the gap ValenceAI is closing. By connecting unstructured field data, automating feedback loops, and breaking down silos - ValenceAI helps pharma teams see the complete picture, in real time. Because better visibility leads to better decisions and better outcomes. Visit https://valenceai.io/ to learn more. #ValenceAI #PharmaIntelligence

I am shaking after every sentence that this panel group says at #CNSSummit today. From how the recipe for success is merging your data with partner data but make sure you don’t compromise on quality of this data. How critical it is to run small experiments with partners before scaling - Venkat Sethuraman To how difficult it is for companies to get their solutions aboard even when AI budgets grow Chuka Esiobu And how essential it is for both companies and solutions to be prepared to work together and have the infrastructure to do that Jared Saul, MD And the one that I just LOVE: Carolyn M. : AI is just a tool. Speaking about RWE does not ring the bell to the business, all they care is how to convince the regulators they are bringing the right value to the right patient population. In end they all summarised what they believe is the big thing now and in the next year: predictably in clinical trials and drug discovery is about to be disrupted 🚀🚀🚀 Bring is on, this is all we care at TrialHub: Make clinical trials more predictable and aligned with patients’ reality. #nounicorns #patientfirst #clinicaltrials

In the lab, experimental design is deliberate and structured. But when it comes to data, many teams underestimate the need for a solid digital foundation — and the complexity of building one. What starts simple often becomes years of costly development, inconsistent records, and systems that break with every upgrade.  The Genedata Biopharma Platform is built for scientific precision, with a data model co-developed with domain experts. It enables: • End-to-end data workflow tracing for audit trails and regulatory confidence   • Structured data capture that eliminates ambiguity and data loss  • A future-proof foundation for scalable, reproducible R&D    Your data deserves the same rigor as your science: https://lnkd.in/d3KSpEiG #DigitalizingBiopharma #DataModels