Clinical Pharmacokinetics (PK) & Pharmacodynamics (PD) Services

hVIVO Consultancy delivers comprehensive non-compartmental PK/PD analysis (NCA), interim readouts and translational modelling & simulation to support confident decision making in early and late clinical development. The 20+ person team brings 25+ years of experience across all drug development phases, using validated software under GCP-based workflows.
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500k+

PK/PD studies delivered

With 97.2% on-time delivery in the last 3 years

30yrs

Years of experience

 Supporting both biotech and pharma across Phase I-III 

>20

Experts

Specialising in NCA PK/PD, biomarkers, ADA analysis, modelling & simulation, and clinical pharmacology 

GCP

GCP-based validated workflows

Using Phoenix WinNonLin®, SAS®, with independent QC and internal peer review

Who We Work With

Start-ups & Biotechs

For startups and biotechs who do not have the internal resource for a PK role, we can work as an extension of your team to support rapid decision-making, fundraising milestones, and efficient PK insights with fast turnarounds.

Mid-Size Biopharma

Ideal for teams needing interim or final PK/PD analyses, dose escalation support, validated NCA outputs, and consistent reporting.

Large Pharma

Scalable PK/PD analysis capacity for complex datasets across multiple therapeutic areas including infectious disease, immunology, cardiometabolic and oncology.

Project manager looking at lap

What This Service Is

We provide a complete suite of clinical pharmacokinetics (PK), pharmacodynamics (PD) and translational modelling & simulation services. These quantify drug exposure, characterise drug effect, and translate preclinical findings into clinical predictions — including safe starting dose strategy for first-in-human studies.

Services include:

  • PK (NCA) and PD analysis
  • Biomarker & ADA analysis
  • Preliminary and interim readouts
  • Translational modelling & simulation to support preclinical to clinical decision-making
  • PK report writing and CSR contributions

Working With hVIVO Our structured, GCP aligned workflow integrates rigorous analytical methodology with expert clinical pharmacology oversight, ensuring each PK/PD and translational modelling project is executed with scientific precision and decision critical reliability

1. Define Objectives & Decision Points

Clarify what is needed for dose escalation, interim reviews, and clinical strategy.

2. Build a Fit-for-Purpose Analysis Plan

Set up NCA and PD workflows aligned to GCP based SOPs.

3. Execute Analyses

All analyses are run using Phoenix WinNonLin and SAS, performed by qualified PK/PD analysts under validated processes.

4. Independent QC + Peer Review

Every dataset, table and calculation is independently checked, with full internal peer review for accuracy and integrity.

5. Deliver Decision Ready Outputs

You receive fully quality checked tables, figures, and interpretation in a standalone report or CSR-ready section, plus access to additional analysis on request.
Clinical staff in white coats talking iStock-1302546472

Scientific Depth and Operational Excellence

We combine scientific depth with operational excellence. With decades of experience across specialist therapeutic areas, a >20person specialist team, and validated GCP aligned workflows, we deliver reliable, on time PK/PD outputs — even for complex datasets and fast-moving clinical programs.

Our adaptive, collaborative approach ensures rapid turnarounds, quality assurance at every step, and flexibility to respond to evolving study needs.

Core Capabilities

Our core capabilities encompass the full spectrum of clinical pharmacokinetic, pharmacodynamic, and translational modelling expertise required to generate robust, high integrity data that underpins confident clinical decision making.

Core Capabilities

  • Non-compartmental (NCA) PK/PD analysis under GCP-based SOPs
  • Preliminary and interim PK/PD analyses and dose escalation support
  • Biomarker and ADA data integration
  • PK report writing & CSR section development
  • Translational modelling & simulation for FIH dose selection, exposure predictions, and preclinical to clinical bridging

FAQ

Yes — all PK/PD analyses follow high quality GCP based SOPs with independent QC.
Yes — hVIVO offers translational modelling & simulation, including preclinical to clinical bridging and starting dose definition.
Yes — preliminary and interim analyses and dose escalation support are explicitly included.
Phoenix WinNonLin® and SAS®.

Talk with our PK/PD and translational modelling team

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