Organize clinical pharmacology and modeling around exposure, response, and dose decisions.
Model outputs depend on data, assumptions, and intended use. Research guides do not replace project-specific clinical or regulatory judgment.
Sources, selection, and corrections →The first six companies in this field’s editorial order, not a separate selection or capability ranking. The full directory uses the same data and order.
Manage field companies & order →
Crystal Bio Solutions describes bioanalytical and biomarker services, biologics characterization and CMC analytics, and clinical pharmacology. Its website lists immunoassay, molecular, cell-based, and mass-spectrometry techniques. Scope and quality requirements should be confirmed for the specific study and site.
The Baltimore CPC lists FIH, carbon-14 human ADME, TQT and DDI, offered as standalone or integrated studies.
Provides PBPK, IVIVC and formulation/clinical-design modeling, available standalone or integrated with its clinical studies.
Certara offers model-informed drug-development services and biosimulation software. Its public portfolio includes Phoenix for PK/PD analysis and Simcyp for PBPK modeling, alongside development and regulatory support. Software availability does not establish a model's fitness for a particular decision.
Simulations Plus offers modeling and simulation software and consulting across discovery and development. Its public software portfolio includes GastroPlus, MonolixSuite, and QSP tools. Modeling choices and validation should follow the intended scientific question.
Allucent describes clinical pharmacology strategy, PK/PD, pharmacometrics, modeling, and simulation. Nuventra is part of Allucent and is not counted here as a separate independent provider.
Original online dates are retained. Guides use accessible articles or abstracts and do not replace reading the paper.
This commentary proposes a lifecycle approach to model-informed decision-making, from discovery and dose selection to regulatory evaluation and reimbursement. It discusses quantitative methods, patient-relevant outcomes, and real-world data, alongside challenges in integration, transparency, and stakeholder acceptance. It is a conceptual roadmap, not a prospective validation of one modeling strategy.
Rajesh Krishna; Ananth Kadambi; Patrick Smith; Piet H van der Graaf; Fran Brown
DOI: 10.1002/jcph.70270
This perspective examines digital-twin claims against established pharmacometric practice. It argues that individual simulation, sequential updating, and decision-focused uncertainty analysis have longstanding roots in PK/PD modeling. The author emphasizes that fundamental limits, including identifiability, remain relevant despite new terminology.
Brett E Houk
DOI: 10.1002/cpt.70340
Manually selected historical and recent original announcements, not presented as today’s news. Source dates, including historical dates, are retained.
Certara launched Bio Venture Catalyst, bringing together scientific development, regulatory, commercial, and investor-oriented strategy. The announcement includes model-informed development support and asset prioritization. The offering is a consulting service; its stated aims do not demonstrate improved clinical outcomes or guarantee financing.
Original announcement ↗