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Advanced Pharmacokinetic and Pharmacodynamic (PK/PD) and drug-disease modeling from SGS Exprimo helps clients make fast and well-informed decisions about their drug development programs and clinical trial design.

Clinical Regulatory Affairs

The implementation of model based approaches in drug development helps to bring new, safe and effective medicines to patients more efficiently. At SGS Exprimo, we are focused on the application of quantitative, model-based approaches at all stages of pharmaceutical development.

With many years experience and the latest software, our modeling and simulation experts provide input that can lead to fewer failed compounds, fewer study failures, and a smaller number of studies needed for registration.

As a standalone activity or in a combination with our characterization, safety and efficacy trial services for bio/pharmaceuticals, we offer the following, including all reports to regulatory standards:

  • Population pharmacokinetics modeling:
    • Study design, analysis and interpretation
    • State of the art absorption/covariate model building
    • Extensive model evaluation
  • Advanced PK/PD modeling:
    • Design of studies and interpretation of results
    • Cutting edge model development
    • Extensive model evaluation
    • Simulations based on final model to aid design the next study
    • PK/PD modeling for biologics and antibodies
    • Pre-clinical PK/PD modeling and inter-species scaling
    • Target mediated drug disposition models
  • Drug-disease modeling:
    • Mechanistic and empirical disease model building
    • New drug positioning in therapeutic area
    • Linking biomarkers to clinical outcome
    • Simulating likelihood of success for clinical trials
  • Pediatrics:
    • Scaling/extrapolation from adult PK and PD data
    • Simulations to aid study design
    • Pediatric Investigation Plan (PIP) preparation and/or review
  • Regulatory consulting/advice with respect to all aspects of modeling during drug development:
    • Reviewing documents prior to regulatory submission
    • Writing summaries of M&S work
    • Mock advisory committee meeting participation
  • Customized training:
    • Basic NONMEM Course (public and on-site)
    • Clinical trial simulation course (public and on-site)

Contact SGS Exprimo today to learn how we can help with your PK/PD modeling and simulation requirements.