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Trial Services

Pharmacokinetics and pharmacometrics

Over the past decade, CHDR’s PK data analysts and pharmacometricians have provided in-depth pharmacokinetic (PK) and pharmacodynamic (PD) analyses to support critical decisions in the development of a range of drugs. Our team is adept at performing non-compartmental analyses and population PK/PD analyses for all types of clinical studies, at all phases of drug development. Our pharmacokinetic and pharmacometric expertise is especially extensive in the field of early clinical drug development.

Pharmacometrics services

CHDR’s pharmacometrics team delivers a range of services, including:

  • timely interim non-compartmental PK analyses to inform decisions related to dose escalation alongside clinical trials
  • final non-compartmental PK analyses for all types of clinical trials
  • concentration-QTc analyses to characterise the relationship between QTc interval and exposure, drawing on Holter ECG data
  • population PK/PD analyses and clinical trial simulations to characterise the pharmacokinetics and the exposure-efficacy and/or exposure-safety relationship, as well as supporting future clinical trials

Predictive PK/PD modelling and simulation at all stages of drug development

With our predictive PK/PD modelling and simulation, we aim to:

  • support study design and dose selection for (first-in-human) clinical studies, drawing on pre-clinical or published data of existing compounds where appropriate. 
  • gain an understanding of variability in exposure and treatment response 
  • establish the response profile of the drug based on measurements obtained using NeuroCart® and PainCart® 
  • optimise PK and PD sampling timepoints to reduce patient burden - facilitate strategic and critical (go/no-go) project decisions 
  • optimise study designs for subsequent clinical studies (e.g. dose selection for a phase II trial)

Data management: Providing clients with customised data management solutions for clinical trials

Our data managers engage seamlessly with both internal and external operational teams from the start of a study until database lock, ensuring timely, high-quality deliverables.

Data management

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