Semantic Coherence: PumasAI – Signal Evidence & AI Readability

Join us on the world stage at our upcoming events.Explore Events
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Our data analytics tools help make data-driven decisions more efficientlyExplore our Products
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Complimentary access to advanced modeling tools for non-commercial research & educationExplore Academic Access
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Find the shortest development path for regulatory approval, with usExplore our Services
[H2] Our offerings are fine-tuned to the needs of drug development and healthcare delivery
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$1BWe save money and time for our 60+ clients
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26Successful regulatory submissions using Pumas products is ever-growing

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Scientific Modeling & ML For Healthcare Data
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Clinical Pharmacology Analysis & Reporting Tool
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Integrated Scientific M&S & AI/ML Tool
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DeepPumas™ brings machine learning directly into nonlinear mixed-effects (NLME) modeling, combining the interpretability of mechanistic models with the flexibility of modern AI. It enables you to extract signal from complex longitudinal data while retaining the statistical rigor and transparency required for decision-making in healthcare and drug development.Hybrid modeling at its core: Seamlessly integrates domain-linked NLME structures with neural network components that capture residual dynamics.Effective in small-data regimes: Leverage prior knowledge and mechanistic structure to overcome sparse datasets—a game‑changer in early development.Uncover hidden relationships: Embed complex predictive factors from patient data directly into models to make richer inferences.Transparent and traceable workflows: Built within Pumas; retains familiar NLME diagnostic workflows with no trade-offs in interpretability or regulatory confidence.Learn more about DeepPumas
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PumasCP is designed to manage your NCA and BE projects most efficiently on a fully compliant platform.Embed SOPs, customize TLFs, tailor reporting, and automate routine analyses.Avoid repetitive tasks, high QC overhead and need for other statistical software.Complete your work most efficiently in qualified and simple to license PumasCP.Learn more about PumasCP
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Pumas gives pharmaceutical/biotech companies a one-stop-shop to support their quantitative work required by regulatory agencies through the drug development cycle.Perform NLME, Optimal Design, Bayesian, SAEM, Clinical Trial Simulations, ML, NCA, BE analyses all within one integrated software.Avoid loss of productivity, cost of maintaining multiple software and lack of latest innovative technologies.Double your think time!Learn more about Pumas

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Model Informed Drug Development (MIDD)Regulatory SubmissionClinical Pharmacology & PharmacometricsNovel Technologies & ModalitiesConsulting LeadershipIt has never been more important to consider utilizing model-based strategies as part of your drug development program.Contact Us
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Model Informed Drug Development (MIDD) ServicesMIDD ServicesDose Translation, Rationale, and Justification
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Establishing the appropriate dosing regimens is critical to maximizing safety and efficacy for patients and clinical trial participants. Our pharmacologists and pharmacometricians are experts in dose translation, selection, and justification across all therapeutic areas, modalities, and stages of development. Utilizing Modeling & Simulation, including the Bayesian approach, proves invaluable in guiding dose selection. Our prowess in this arena is exemplified by the impressive capabilities of Project Optimus.
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Bridging & Extrapolation Approaches 505(B)(2) Pathway
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When planning your pediatric development or 505(b)(2) development program, you must determine how to support the efficacy and safety. You can leverage existing knowledge to bridge efficacy and safety to the new population or new product or new dosing regimen. We specialize in the nuanced science of extrapolating pediatric efficacy.
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Modeling and Simulation
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Using modeling and simulation, existing data can be leveraged to provide critical insights on product safety and effectiveness as related to drug concentration. They can guide trial design, provide evidence of effectiveness and support labeling.
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[H3] Let us partner with your team on
bringing new therapies to light.
Get in TouchTestimonialsPumasAI worked with us with incredible flexibility and agility despite tight timelines and sometimes the need for re-work or additional evaluation, as often is the case with data driven exercises. Samira Merali, PharmD, MSSR. Director & Cardiovascular Therapeutic Head, Clinical Pharmacology and Pharmacometrics
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We are impressed by the quality and breadth of the experience of PumasAI scientists in collaborating with us on modeling and simulation projects across our pipeline spanning investigational therapeutics and vaccines at various stages of clinical development.​Husain A. PhDDirector, Head of Clinical Pharmacology and Pharmacometrics
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...The collaboration spans across the continuum of the drug development cycle, Clinical Development, Clinical Pharmacology, Pharmacometrics, Regulatory, and Strategy. One of these collaborations for a cardio-renal asset, has resulted in a precedent-setting registration pathway where the conventional approach was not viable...Arash Raoufinia, MS, PharmD VP Head of Early Phase Development and Translational Medicine at Otsuka Pharmaceutical Companies (U.S.)
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We have a high priority oncology drug development portfolio at our company. PumasAI provided us with high quality MIDD work product which supported regulatory submissions in a timely manner. It is a pleasure to work with PumasAI scientists, and we highly recommend them!Balaji Agoram, PhDVP & Head of Clinical Pharmacology, Arcus BioSciences
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PumasAI is a valued partner and works very hard to help us achieve our goal. I would recommend PumasAI highly.Jinshan Shen, PhDVP & Head of Clinical Pharmacology, Relay Therapeutics
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Upcoming EventsPast EventsView as Calendar ListAll EventsConferenceLaunchWebinarWorkshopMay 27, 2026WEBINAR
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In-Silico Clinical Trials with NLME Models: A Pumas Demonstration on a Hepatitis B QSP ModelREAD MOREJune 1, 2026WORKSHOP
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Onsite PAGE 2026: Scientific ML for Pharmacometrics with DeepPumasREAD MOREJune 2, 2026CONFERENCE
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PAGE 2026: Leading the new frontier in drug development with QSP+AIREAD MOREJuly 31, 2026CONFERENCE
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Socmathpharm 2026READ MORESeptember 27, 2026CONFERENCE
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ACCP Annual Meeting 2026READ MOREOctober 11, 2026CONFERENCE
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ACoP 2026: From Models to Medicines, FasterREAD MORE