IDDI - Regulatory Statistics & Clinical Data Science Experts

🚩 Did You Know: 33% 𝐨𝐟 𝐝𝐢𝐬𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐞𝐝 𝐫𝐚𝐫𝐞 𝐝𝐢𝐬𝐞𝐚𝐬𝐞 𝐭𝐫𝐢𝐚𝐥𝐬 𝐟𝐚𝐢𝐥 𝐟𝐨𝐫 𝐣𝐮𝐬𝐭 𝐨𝐧𝐞 𝐩𝐫𝐞𝐯𝐞𝐧𝐭𝐚𝐛𝐥𝐞 𝐫𝐞𝐚𝐬𝐨𝐧… A study analyzing 199 𝐝𝐢𝐬𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐞𝐝 𝐫𝐚𝐫𝐞 𝐝𝐢𝐬𝐞𝐚𝐬𝐞 𝐭𝐫𝐢𝐚𝐥𝐬 found that insufficient patient accrual was the primary cause (PLoS Med. 2019 Nov. e1002966). That means one-third of rare disease trials don’t fail because of science, but because they can’t find enough patients. And this can be entirely preventable, but only with the right strategy. For example, we’ve seen sponsors make this mistake: focusing on a single-region strategy, only to realize too late that their target population was scattered across multiple countries. Recruiting for rare disease trials often requires a global approach, but many sponsors fail to plan for multi-country (or even multi-continent) recruitment early enough. 𝐇𝐨𝐰 𝐭𝐨 𝐏𝐫𝐞𝐯𝐞𝐧𝐭 𝐑𝐞𝐜𝐫𝐮𝐢𝐭𝐦𝐞𝐧𝐭 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬: ➡️ Early site selection strategies to identify high-potential regions. ➡️ Global feasibility assessments to anticipate recruitment delays. ➡️ Collecting data in a consistent/standardized way to make regulatory approvals easier and faster. Follow us for more details on how to protect your trials: https://lnkd.in/eEEWvMS7 #RareDiseases #ClinicalTrials #PatientRecruitment #Biostatistics #TrialPlanning #DrugDevelopment #ClinicalResearch #IDDI

🎙️ 𝐍𝐞𝐰 𝐏𝐨𝐝𝐜𝐚𝐬𝐭 𝐄𝐩𝐢𝐬𝐨𝐝𝐞 𝐎𝐮𝐭 𝐍𝐨𝐰! Episode 4 of the #IDDI Podcast Series: The FDA's Project Optimus features Leandro Garcia Barrado and Elisabeth (Els) Coart as they explore the role of randomized trials for dose optimization and have a closer look at how dose optimization can potentially be integrated in seamleass Phase 2-3 Trials. Listen now and follow us for more 👉 https://lnkd.in/esC8pBdu #IDDIPodcast #doseoptimization #dosefinding #cancer #drugdevelopment #IDDIRaleigh #clinicaltrials #clinicalresearch #randomization

👋 Ready to see #IDDI team in action at #ACDM25 at booth #22 We are excited to be both exhibiting and having our CEO Tim Davis speaking at the ACDM: Association for Clinical Data Management : Think Tank! Bring your questions to this expert-led discussion or swing by our booth #22 to explore how we can accelerate your upcoming #clinicaltrials! See you there: https://lnkd.in/en9dykc3 #clinicalresearch #clinicaldatamanagement #ACDM

🚩 Did You Know: 33% 𝐨𝐟 𝐝𝐢𝐬𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐞𝐝 𝐫𝐚𝐫𝐞 𝐝𝐢𝐬𝐞𝐚𝐬𝐞 𝐭𝐫𝐢𝐚𝐥𝐬 𝐟𝐚𝐢𝐥 𝐟𝐨𝐫 𝐣𝐮𝐬𝐭 𝐨𝐧𝐞 𝐩𝐫𝐞𝐯𝐞𝐧𝐭𝐚𝐛𝐥𝐞 𝐫𝐞𝐚𝐬𝐨𝐧… A study analyzing 199 𝐝𝐢𝐬𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐞𝐝 𝐫𝐚𝐫𝐞 𝐝𝐢𝐬𝐞𝐚𝐬𝐞 𝐭𝐫𝐢𝐚𝐥𝐬 found that insufficient patient accrual was the primary cause (PLoS Med. 2019 Nov. e1002966). That means one-third of rare disease trials don’t fail because of science, but because they can’t find enough patients. And this can be entirely preventable, but only with the right strategy. For example, we’ve seen sponsors make this mistake: focusing on a single-region strategy, only to realize too late that their target population was scattered across multiple countries. Recruiting for rare disease trials often requires a global approach, but many sponsors fail to plan for multi-country (or even multi-continent) recruitment early enough. 𝐇𝐨𝐰 𝐭𝐨 𝐏𝐫𝐞𝐯𝐞𝐧𝐭 𝐑𝐞𝐜𝐫𝐮𝐢𝐭𝐦𝐞𝐧𝐭 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬: ➡️ Early site selection strategies to identify high-potential regions. ➡️ Global feasibility assessments to anticipate recruitment delays. ➡️ Collecting data in a consistent/standardized way to make regulatory approvals easier and faster. Follow us for more details on how to protect your trials: https://lnkd.in/eEEWvMS7 #RareDiseases #ClinicalTrials #PatientRecruitment #Biostatistics #TrialPlanning #DrugDevelopment #ClinicalResearch #IDDI

💙 As February begins, we look ahead to #RareDiseaseDay on the 28th, a time to honor and recognize those living with and battling against rare diseases. This month, we're sharing insights to help rare disease trials succeed, as unfortunately, too many trials struggle to recruit enough patients, delaying treatments advancements and new standards of cares. Rare disease trials require specific and proactive recruitment planning. Are you confident your trial is prepared to find patients efficiently and avoid these challenges? Follow us for more information on how to protect your trials 👉 https://lnkd.in/ezU_6Rw9 #IDDIcares #RareDiseaseMonth #rarediseases #rarediseaseawareness #cro #clinicaltrials #clinicalresearch #ShowYourColors #RareDiseaseDay2025

Wrapping up an incredible week at #SCOPESummit in Florida! 🌴   Our team of Sébastien Coppe, PhD and Samuel Salvaggio, PhD had a fantastic time connecting with industry leaders, sharing insights, and showcasing One2Treat. Sebastien took the stage to present One2Treat, discussing how we can integrate multiple patient-relevant outcomes into a single endpoint for more patient-focused and efficient clinical trials 🚀   Special thanks to our partners at IDDI - Regulatory Statistics & Clinical Data Science Experts (Serge Bodart, Matthew Belcher, Jeremy Edwards and Tara Kervin) for the shared booth space.   Check out the gallery below for some highlights from the event! 📸   #ClinicalTrials #SCOPESummit2025 #PatientFocused

❌❗...“𝘛𝘩𝘢𝘵 𝘤𝘰𝘶𝘭𝘥 𝘩𝘢𝘷𝘦 𝘣𝘪𝘢𝘴𝘦𝘥 𝘵𝘩𝘦 𝘳𝘦𝘴𝘶𝘭𝘵𝘴 𝘢𝘯𝘥 𝘭𝘦𝘥 𝘵𝘰 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘤𝘩𝘢𝘭𝘭𝘦𝘯𝘨𝘦𝘴, 𝘧𝘪𝘯𝘢𝘯𝘤𝘪𝘢𝘭 𝘭𝘰𝘴𝘴𝘦𝘴, 𝘢𝘯𝘥 𝘳𝘪𝘴𝘬𝘴 𝘵𝘰 𝘱𝘢𝘵𝘪𝘦𝘯𝘵 𝘴𝘢𝘧𝘦𝘵𝘺".. Most trial sponsors assume randomization is enough to prevent bias, but one randomization issue can invalidate an entire study! In one trial we supported, 𝐥𝐨𝐰 𝐞𝐧𝐫𝐨𝐥𝐥𝐦𝐞𝐧𝐭 𝐚𝐭 𝐦𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐜𝐞𝐧𝐭𝐞𝐫𝐬 caused an imbalance that could have biased the results and led to financial losses, regulatory delays, and risks to patient safety. ✔️ Here’s what worked: By combining #Statistical Services and #Randomization Services, we detected the imbalance early and corrected it by adapting the randomization algorithm. The imbalance was corrected, and the trial stayed on track, ensuring its integrity and maintaining compliance with regulatory expectations. Check out our latest blog by Facundo Zaffaroni to explore the strategies we used and see if you have a system in place to prevent these risks: https://lnkd.in/eaeV2k6v If you're not 100% confident your trials are fully optimized, it’s time to talk! Your future approvals depend on it: https://lnkd.in/eBdKch4p #IDDI #ClinicalTrials #Randomization #Biostatistics #TrialManagement #ClinicalResearch #PatientSafety #PharmaInnovation #ResearchSolutions #DrugDevelopment #RegulatoryCompliance #TrialOptimization #PharmaScience

🎧 𝐍𝐞𝐰 𝐞𝐩𝐢𝐬𝐨𝐝𝐞 𝐚𝐥𝐞𝐫𝐭! The #IDDI's Project Optimus Podcast series continues with Episode 3: 𝐑𝐨𝐥𝐞 𝐨𝐟 𝐏𝐊/𝐏𝐃 𝐢𝐧 𝐝𝐨𝐬𝐞 𝐟𝐢𝐧𝐝𝐢𝐧𝐠 𝐚𝐧𝐝 𝐝𝐨𝐬𝐞 𝐨𝐩𝐭𝐢𝐦𝐢𝐳𝐚𝐭𝐢𝐨𝐧 Listen to Vaiva Deltuvaite - Thomas and Jennifer Menda as they walked through these crictical aspects: ✔️ Current context of PK/PD modelling in oncology ✔️ Integrating PK modelling analyses in dose finding and dose optimization ✔️ Role of PD in the early dose finding trials Tune in and learn how #ProjectOptimus is opening up exciting prospects and opportunities including the possibilities that PK/PD analyses will bring to cancer treatments! More information here: https://lnkd.in/gr9xfAyB #IDDIPodcast #doseoptimization #dosefinding #cancer #drugdevelopment #IDDIRaleigh #clinicaltrials #clinicalresearch #pkpdmodelling

🎗️This #WorldCancerDay, we reaffirm our commitment to transforming cancer care. At #IDDI, we stand alongside the global scientific community to drive progress in #oncology research. Our dedication goes beyond data and statistics - we focus on research that places patients at the heart of cancer treatments. With 880+ oncology trials conducted over the years, we continue to push the boundaries of innovation, striving for better outcomes, improved recoveries, and a future where cancer care is more effective and personalized. Together, we can make a difference! Discover our latest white paper on #DoseOptimization in oncology trials here: https://lnkd.in/eVaVdwYs #WorldCancerDay2025 #clinicaltrials #UnitedByUnique #patientcentric #cancertreatments

🔴 LIVE from EUCROF 2025 in #Copenhagen! Come discuss with our experts at Booth #13 while enjoying some Belgian treats 🍫 See you there!