Quantitative Clinical Development(QCD)

Using data management, modeling and simulation to optimize your chances of clinical success with your clinical trial design and clinical testing.

Quantitative Clinical Development (QCD) combines 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. Model-based Drug Development (MBDD) can be implemented at any phase to improve the efficiency of clinical development by providing quantitative justification for clinical trials design, dose selection, and decisions 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.

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

Parexel’s QCD group provides expertise in the strategic implementation of modeling & simulation services to help clients make smarter clinical data management and drug development decisions for a smoother journey to market. Led by Frank Hoke, Ph.D., Vice President of QCD, our team has a cumulative 400+ years of direct clinical research and clinical development experience with more than 15 Modeling & Simulation scientists who apply state-of-the-art methodologies across 10+ therapeutic areas to drive milestone development decisions for first-In-human, proof-of-concept, phase IIb dose ranging and successful registration.

Therapeutic Expertise Includes:

  • Oncology
  • Infectious Diseases
  • Rare Diseases
  • Cardiology/Renal
  • Neurology/Psychiatry
  • Metablolism/Endocrine
  • Respiratory
  • Immunology
  • Dermatology
  • Gastroenterlogy
  • Hematology
  • Hepatology
  • Rare Disease

 

Services include:

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

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

Pharmacometrics

  • PK/PD Analysis for safety and efficacy
  • Mechanistic modeling  and simulation
  • Dose and dosing regimen selection
  • Disease  & placebo models
  • Clinical studies and trial simulation

Systems Pharmacology

  • Systems model development for selected targets
  • Identification of relevant biomarkers
  • Prediction of likelihood of achieving target profile
  • Integration of genetic markers to phenotype patient sub-populations

PK analysis & programming

  • Noncompartmental PK Analysis
  • PK simulations for various scenarios
  • PK programming support
  • Nonmem dataset generation

We are always available for a conversation.

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