Our Services

qPharmetra provides innovative pharmacometric consulting services with close attention to consistent, high quality work processes.

  • PK Analysis

    Characterize and explore your drug's kinetics for reports and insights into patient effects

    PK Analysis Illustration
    • What is the extent of exposure to our drug?
    • What is the impact of between-patient variability? How large is it?
    • Do we need to reformulate?
    • Is there a gender difference? Is exposure different in Asia/Africa/Europe?
    • Pre-clinical and clinical PK
    qPharmetra can help!
    • From simple non-compartmental to complex non-linear mixed effects, population PK modeling, qPharmetra has the know-how to find these answers
    • Your Result: qPharmetra's systematic approach, automation, quality processes, and standardized reporting give you robust, submission-ready results
  • PK/PD Analysis

    Predict your dose-response for efficacy, tolerability and safety

    PK-PD Analysis Illustration
    • What is our exposure-response?
    • What doses should we test?
    • Do we know the minimally effective dose?
    • How many adverse events are expected at higher doses?
    • How would a reformulation affect efficacy and tolerability?
    • How do different populations respond?
    qPharmetra can find pragmatic answers to these questions
    • Quantifying the crucial yet uncertain relationships between increased exposure and efficacy or side effects is critical to your success.
    • PK/PD modeling concretely describes the performance characteristics of your drug
    • We take into account the mechanism of action, patient characteristics and the impacts of dose and time
    • Enable Dose selection, trial Design, partnering discussions, and regulatory Submissions
    • Your Result: Robust and Clear Predictions of Efficacy, Safety and Tolerability
  • Virtual Trials

    Gauge your next trial's probability of success and test alternative designs before you invest

    Virtual Trials Illustration

    • What is the best design for the next trial?
    • Which patient populations will maximize the chance of success?
    • What is our probability of success against the standard of care?
    • Do we need a PoC trial?
    qPharmetra has the Expertise and Computing Power to Solve these Problems
    • qPharmetra are experts at using Clinical Trial Simulation (CTS) to “war game” alternatives and hypothetical scenarios before investing in the next trial
    • We use simulation to turn models of your data into data-based recommendations
    • Your Result: Design trials that maximize the probability of trial and program success
  • Model-Based Meta-Analysis

    Use publicly available data to model the competitive landscape; Locate your drug in a crowded market

    • Is this drug better than the standard of care?
    • Where will it fit in the competitive landscape?
    • What is the placebo response? What is the time-course of disease progression?
    • Which biomarkers predict clinical success?
    • How do different populations respond to each drug in this area?
    qPharmetra Uses Model-Based Meta-Analysis to Position Products in Competitive Markets
    • Glean insight from public data (literature, regulatory, conference proceedings)
    • Leverage other companies’ public data to learn from previous experience about biomarkers and clinical endpoints
    • Your Result: Know where your drug falls relative to competitors before you invest in expensive trials
  • Clinical Utility Analysis

    Link your scientific data to quantitative measures of net patient benefit to guide development

    Clinical Utility Illustration
    • Can we beat the standard of care?
    • Which effects of the drug are most important?
    • Which of these drives value? Uncertainty?
    • Do we continue with this program?
    • What is the “best” dose given efficacy and safety trade-offs?
    • Do we need to reformulate to avoid adverse effects, and if so what is the best way?
    We are Experts with the Techniques to Answer these Questions
    • Clinical Utility Analysis employs proven tools from the field of Decision Analysis to measure efficacy and safety trade-offs
    • qPharmetra has extensive experience in both the math and the process of assessing clinical utility
    • Your Result: Bring teams together to assess a new drug’s strengths and assess the importance of liabilities
  • Mechanistic Models

    Use knowledge of underlying processes to extrapolate beyond observed conditions

    Mechanistic Model Illustration
    • How influential is the target vs. off-target pharmacology?
    • How long is the effect expected to persist after disappearance of measurable drug?
    • Are drug-target interactions sufficiently strong to influence physiology?
    • How will the mechanism of action translate to the clinical setting?
    • Does enough of the get to the site of action to have a clinical effect?
    Mechanistic, physiologically based models help to answer these questions:
    • Incorporate known mechanistic complexity into the modeling process
    • Integrate the right amount of biological complexity to enable key decisions
    • Simplify complex mechanistic representations to identify influential steps
    • Identify critical thresholds for the difference between disease and health
    • Your Result: A clear understanding of how your drug interacts with the biological target and what the downstream consequences are
  • Decision Analysis

    Leverage your data to estimate your program's probability of success, financial ramifications and business case

    Decision Analysis Illustration

    • What is the value of my next trial? Is it worth doing?
    • Do we continue with this program?
    • Should we in-/out-license?
    • Can we beat the standard of care?
    • What is our probability of success?
    qPharmetra Extends the Impact of Pharmacometrics with the Field of Decision Analysis
    • Your development strategy should be systematically integrated with your data analysis
    • qPharmetra has unique experience combining Pharmacometrics with Decision Analysis
    • Your Result: Data-driven strategy and robust assessment of risk and reward