Our Services

Our general service offerings (with all reports to regulatory standards) include:

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