Clinical Pharmacology, PK/PD and Translational Modeling & Simulation

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Ensuring the success of your product development with decades of proven expertise

In drug development, a solid clinical development strategy, implemented at an early stage of product development, is crucial to guide the success (and cost-effectiveness) of product development. Understanding the kinetics of a drug, including absorption, distribution, metabolism, and elimination, as well as its biochemical and physiological effects, is fundamental to optimizing therapeutic outcomes. With over 25 years of experience, Venn Life Sciences has extensive experience in supporting pharma companies of all sizes with non-compartmental (NCA) pharmacokinetics (PK), pharmacodynamics (PD), biomarker, and anti-drug antibodies (ADA) analyses, along with translational modelling & simulation and clinical pharmacology consultancy, covering all Phase 1 and Phase 2/3 studies. Our team of > 30 experts are ready to support you through this critical phase, providing the insights and strategies needed to safely and effectively move your drug from preclinical through all clinical stages.

Proven excellence in (NCA) PK/PD Analysis: 500+ studies with 97.2% on-time delivery over the last 3 years

Our team of experts specializes in delivering fast turnarounds and handling large, complex PK/PD datasets. Over 60% of our work focuses on complicated studies, such as oncology, with ample experience in immunology, infectious, cardiovascular, rheumatology, neurology and other diseases. Additionally, we have extensive experience in various clinical pharmacology studies, including single ascending dose (SAD), multiple ascending dose (MAD), drug-drug interaction, and hepatic/renal impairment studies. We are recognized for our accuracy and integrity, and strong commitment for client satisfaction. With decades of experience across various types of drug candidates, matrices, and therapeutic areas at every phase of development, we deliver high-quality results and make swift, reliable decisions to meet timelines. At the same time, we remain highly flexible to easily accommodating additional requests. Each PK/PD analysis is performed by competent and qualified staff, according to high-quality GCP based Standard Operating Procedures (SOPs) using validated software, like Phoenix WinNonLin, SAS, and R. To ensure the highest standards, all data and calculations are independently checked for quality before the report is peer reviewed internally.

Our team can assist you with:

End-to-End PK/PD Study Support

  • Preliminary/interim analyses, and dose escalation support
  • Complete final analyses, and regulatory support
  • Protocol writing
  • Clinical PK(/PD) analysis plan
  • Data transfer agreement
  • Project management
  • Data management
  • Data analysis, reporting and interpretation
    • Analytical and clinical data review
    • Dataset programming
    • NCA PK/PD analysis in compliance with GCP-based SOPs using validated software (Phoenix WinNonLin, SAS, R)
    • Tables, Listings, and Figures (TLFs)
    • Data transfer files for SDTM and ADaM
    • PK/PD interpretation by consultants
    • Writing PK Report or relevant sections in Clinical Study Report (CSR)
    • Quality Control (QC) & Quality Assurance (QA)

Clinical Pharmacology Consultancy

  • Transition from preclinical to clinical phase (defining a safe starting dose in human by means of fit-for-purpose translational modelling & simulation)
  • Pharmacometrics consultancy (including project management and oversight of pharmacometrics projects)
  • Clinical pharmacology program consultancy

Learn more about Clinical Pharmacology, PK/PD and Translational Modeling & Simulation

Ready to see how Venn Life Sciences could speed up your drug development program?
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