Clinical Pharmacology, Modeling and Simulation

Optimize your chances of clinical success

Our clinical pharmacology, modeling and simulation solutions combine clinical pharmacology modeling and simulation with clinical PK/PD and pharmacometrics for a more strategic approach to clinical development, reducing the time and cost of bringing drugs to the market. By leveraging mathematical models for a quantitative analysis of the relationship between drugs, disease and patients, modeling and simulation can predict a drug’s benefits and adverse effects in a patient population prior to conducting a clinical trial or clinical research – minimizing the patient burden for your drug development journey. 

The effective use of modeling and simulation across all phases of drug development has the ultimate benefit to patients by maximizing the value of their data.  Quantitative methodologies such as population pharmacokinetic analysis (PopPK) and physiologically based pharmacokinetic (PBPK) modeling allow for greater exploration and hypothesis-testing without the need for a trial and new patient exposure at every turn.   

Our experienced team of modelers and pharmacometricians can help you understand your drug in hepatic or renal impaired patients, patients of differing ethnicities, pregnant and/or lactating women or patients with other special physiologies (such as obesity) – keeping the patient at the heart of everything we do.

Model-informed Drug Development (MIDD) can be implemented at any phase to improve the efficiency of clinical development by providing quantitative justification for clinical trial design, dose selection, assessment of the potential for drug-drug interactions, during clinical testing and trial execution. In addition, use of quantitative clinical studies in pharmacology throughout the lifecycle of a drug candidate supports high quality regulatory packages to help secure regulatory approval.

Engage our experts in modeling and simulation as your in silico drug development partner. Long before your drug will be used to treat patients at the bedside, our seasoned pharmacometricians will work to expand and maximize the value of each patient’s exposure and response data using both industry standard and proprietary analysis software.  From beginning to end, Parexel’s Clinical Pharmacology, Modeling and Simulation scientists work in partnership with your drug development team to help plan and execute your drug development journey - always putting patients first. 

The path to smarter drug development is clear with Parexel’s modeling, data management and simulation expertise.

Parexel’s Clinical Pharmacology, Modeling and Simulation group provides expertise in the strategic implementation of modeling & simulation solutions to help clients make smarter patient-driven drug development decisions for a smoother journey to market. Our therapeutic expertise includes multiple and varied therapeutic areas. 

Solutions include:

Quantitative clinical pharmacology - optimize clinical trials through modeling and clinical trial simulations.

• Strategic implementation of model-informed drug development
• Regulatory submissions & labeling to ensure compliance with regulations at all levels
• Biosimilar & biobetter development strategies to assess the safety of drugs
• Pediatric development (PIP/PSP)

Pharmacometrics

• PK/PD Analysis for safety and efficacy
• Mechanistic modeling  and simulation
• Physiologically based Pharmacokinetic (PBPK) modeling
• Population Pharmacokinetic (PopPK) Modeling
• Dose and dosing regimen selection
• Disease  & placebo models
• Clinical studies and trial simulation

PK analysis & programming

• Non-compartmental PK Analysis
• PK simulations for various scenarios
• PK programming support
• NONMEM dataset generation