💡 𝟖𝟎𝟎 𝐩𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬 joined the EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) Regulatory Statistics Workshop in Basel to hear from One2Treat Founder Marc Buyse and Senior Trial Design Lead Samuel Salvaggio, PhD on “𝐓𝐞𝐬𝐭𝐢𝐧𝐠 𝐏𝐫𝐨𝐜𝐞𝐝𝐮𝐫𝐞𝐬 𝐟𝐨𝐫 𝐌𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭𝐬 & 𝐎𝐮𝐭𝐜𝐨𝐦𝐞𝐬.” 🔍 Regulators challenged the team: “𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐞𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐢𝐬 (𝐭𝐡𝐞 𝐍𝐞𝐭 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐁𝐞𝐧𝐞𝐟𝐢𝐭) 𝐭𝐨 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬?” Marc responded with a smile: “𝐇𝐚𝐯𝐞 𝐲𝐨𝐮 𝐞𝐯𝐞𝐫 𝐭𝐫𝐢𝐞𝐝 𝐞𝐱𝐩𝐥𝐚𝐢𝐧𝐢𝐧𝐠 𝐭𝐡𝐞 𝐡𝐚𝐳𝐚𝐫𝐝 𝐫𝐚𝐭𝐢𝐨 𝐭𝐨 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬?” 😎 Curious about the Net Treatment Benefit and how it can make clinical outcomes easier to understand? 👉 Visit our website or get in touch to learn more: www.one2treat.com #ClinicalTrials #Statistics #EFSPI
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Data Scientist and a Biostatistician. Developer of ML/AI models. Researcher in the fields of Biology and Clinical Research. Helping companies with Digital products, Artificial intelligence, Machine Learning.
✅ A highly important aspect in a Meta-analysis. In addition to choosing and implementing the right approaches its very important to document them too! This is important both from scientific and regulatory perspectives and especially important in areas such as Meta-analysis in Clinical Trials, other Clinical Research areas and Pharmaceutical industry. In addition to other data/ clinical / methodological aspects its important to document : ✔ The weighting method in general ✔The estimator of tau^2 ✔The method for confidence interval calculation in Frequentist meta-analysis ✔The method for credible interval calculation in Bayesian meta-analysis ✔ Prior definition in a Bayesian meta-analysis ✔Fixed / Random effects approach documentation ✔Documentation for Publication bias assessment ✔Documentation for potential Leave one out analysis ✔Documentation for other risk of bias tools used ✔Documentation for Software / Package used ✔ For a more systematically advanced approach - Estimand definition in a meta-analysis ✔ Endpoint definition both from Clinical and Statistical perspective ✔ Potential meta-regression approach definition ✔ Method specific Sensitivity analysis documentation by Darko Medin #metaanalysis #documentation #regulatory #statistics #clinical #research #analysis #datascience #pharmaceutical #slr #systematicreview #biostatistician
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Are you ready to navigate your way through a successful #Annex 1 inspection? Join us for an exclusive event hosted by NIBRT National Institute for Bioprocessing Research and Training and Cencora PharmaLex. 📅 Event: Navigating a Successful #Annex 1 Inspection 🕒 Date: May 9th, 2024. 📍 Location: NIBRT, Dublin. Hosted by industry experts, this event is a must-attend for anyone involved in pharmaceutical manufacturing, quality assurance, or regulatory affairs. Here's what you can expect: 🔍 In-depth insights into #Annex 1 requirements 📝 Practical tips for compliance and inspection readiness 💡 Strategies for addressing #Annex 1 challenges 🤝 Networking opportunities with industry experts. Don't miss this chance to enhance your understanding and boost your confidence in #Annex 1 compliance. This event includes a tour of the new cell and gene facility at NIBRT. Register now to secure your spot 🔗 https://lnkd.in/etCREG9Z See you there! 👥 #annex1 #Annex1 #Compliance #RegulatoryExcellence #PharmaIndustry #Inspection #Pharma #pharmaceuticalindustry
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Southern European Account Manager - Digital Science (LIMS | ELN | LES | SDMS | SQC | Data Analytics | Mobile | Integration)
🚀 Last week, we had the opportunity to attend Farmaforum 2024, a key event for connecting with clients and colleagues in the pharmaceutical industry. I had the pleasure of being accompanied by Javier Fraile, our Solutions Manager. 🌐 Digital transformation remains a priority in this sector, and we are proud that our solutions are at the forefront of this evolution. 💡🔍 Strengthening our relationships and staying up-to-date with emerging trends in laboratory digitalization and automation is essential for refining our digital offering. 🔄📊 Our commitment is clear: to provide tools that enhance operational efficiency and accuracy in laboratory data management. In this way, we continue to lead the digital transformation in the pharmaceutical industry. 🏆💼 #Farmaforum2024 #DigitalTransformation #LIMS #PharmaceuticalIndustry #Innovation #Automation #connectedlab #thermofisherscientific #samplemanager #lims #digitalsciencesolutions
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Pharma Insights 2024 is now available on-demand! Watch now to hear and gain valuable insights from experts in the field discussing the trends shaping analytical workflows in the #pharma industry. Watch on-demand: https://bit.ly/3J9VafN
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🧪 Precision in Every Data Point: Bioanalytical Excellence 🔬 🔍 Why Choose A4P - A LabConnect Company ⁉ A4P’s Expert Team: Our consultants are bioanalytical and biomarker experts with many years of scientific insight, to enhance your program development. Regulatory Compliance: A4P adhere to GLP/GCP guidelines to ensure your data meets global regulatory requirements. Customer-Centric Approach: A4P adapts to your needs, offering customised solutions for bioanalytical and biomarker strategy and oversight to ensure your projects remain on track. Whether you’re working in early drug discovery or late-stage clinical trials, A4P - A LabConnect Company is your partner for reliable bioanalytical consultancy. 📩 Connect with us to learn more about how we can support your bioanalytical needs. Visit www.a4pbio.com or reach out at Nicola Hickson. #Bioanalytical #Pharmacokinetics #BiomarkerAnalysis #PK #BIOMARKERS #DrugDevelopment #LifeSciences #A4P #DIDYOUKNOW #LABCONNECT
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🚀 Join Kevin Bittorf for an insightful discussion on the practical applications of AI in the pharmaceutical industry. From accelerating drug discovery to optimizing manufacturing processes, AI is transforming the way we innovate in pharma. We’re thrilled to have Keith Parent join Kevin for this dynamic conversation. Don't miss out on the opportunity to explore how AI is shaping the future of healthcare. 📅 Date: September 25th 🔗 Register below Let’s dive into the future together!
2pm EDT on Wednesday, September 25th: Learn how drug developers implement and utilize AI in pharmaceutical development. Our upcoming Formulation Forum webinar will detail the roles of the AI implementation expert and user for leveraging data management and integration. We welcome co-speakers Keith Parent (“Implementation Expert”) and Kevin Bittorf, Ph.D., (“The User”) in this month’s episode to share their 50 years of combined experience, including: 🔹 AI implementation and utilization for drug development 🔹 Data storage, verification, and reliability 🔹 Tools for simplifying complex workflows, improving decision-making, and ensuring regulatory compliance 📅 Register and view the full abstract for September 25th at 2pm EDT: https://lnkd.in/eQyaTH-t #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
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Looking forward to attending the Pharmaceutical Management Science Association (PMSA) Annual Conference 2024 with Indegene! Our poster presentation will be focused on tackling #lifesciences challenges and exploring new ideas to create a #FutureReadyHealthcare. Join the conversation and learn more about the latest industry developments. #HCP #Data #Analytics
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Passionate about supporting statisticians to continuously challenge the status quo. | "The most meaningful way to succeed is to help others succeed." (Adam Grant) | "A man who casts no shadow has no soul." (Iron Maiden)
Check out this seminar on application of causal inference to RCTs! I will talk about why I think clinical trial statistician should now about causal inference, and where I anticipate these methods will help us in drug development moving forward. Tune in, the webinar is free for members and non-members! #biostatistics #causalinference EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) PSI: Statisticians in the Pharmaceutical Industry
On November 19th, we will host our first webinar, marking the launch of our PSI special interest group on causal inference. Kaspar Rufibach (Merck), Susan Gruber (TL Revolution) and Florian Lasch (EMA) will discuss opportunities to apply a causal inference framework to the analysis of RCT data. For more information: https://lnkd.in/eeSdgNbS Join us by registering here: https://lnkd.in/eQPTAjVc Kelly Van Lancker Alex Ocampo Jesper Madsen Tim Morris PSI: Statisticians in the Pharmaceutical Industry
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We have in-depth experience providing statistical expertise for data monitoring committees. Read more on the #biostatistics support we provided for a study assessing a novel COVID-19 therapeutic at https://bit.ly/3vKCVtE. #clinicaltrials #biotech #pharma #idmc #dsmb #biostatistics #respiratory
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2pm EDT on Wednesday, September 25th: Learn how drug developers implement and utilize AI in pharmaceutical development. Our upcoming Formulation Forum webinar will detail the roles of the AI implementation expert and user for leveraging data management and integration. We welcome co-speakers Keith Parent (“Implementation Expert”) and Kevin Bittorf, Ph.D., (“The User”) in this month’s episode to share their 50 years of combined experience, including: 🔹 AI implementation and utilization for drug development 🔹 Data storage, verification, and reliability 🔹 Tools for simplifying complex workflows, improving decision-making, and ensuring regulatory compliance 📅 Register and view the full abstract for September 25th at 2pm EDT: https://lnkd.in/eQyaTH-t #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
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