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.
PK/PD studies delivered, with 97.2% on-time delivery in the last 3 years
Years of experience supporting both biotech and pharma across Phase I-III
Experts specialising in NCA PK/PD, biomarkers, ADA analysis, modelling & simulation, and clinical pharmacology
Validated GCP-based workflows using Phoenix WinNonLin®, SAS®, with independent QC and internal peer review
For startups 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.
Ideal for teams needing interim or final PK/PD analyses, dose escalation support, validated NCA outputs, and consistent reporting.
Scalable PK/PD analysis capacity for complex datasets across multiple therapeutic areas including infectious disease, immunology, cardiometabolic and oncology.
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:
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.
Clarify what is needed for dose escalation, interim reviews, and clinical strategy.
Set up NCA and PD workflows aligned to GCP based SOPs.
All analyses are run using Phoenix WinNonLin and SAS, performed by qualified PK/PD analysts under validated processes.
Every dataset, table and calculation is independently checked, with full internal peer review for accuracy and integrity.
You receive fully quality checked tables, figures, and interpretation in a standalone report or CSR-ready section, plus access to additional analysis on request.
Our core capabilities encompass the full spectrum of clinical pharmacokinetic, pharmacodynamic, and translational modelling expertise required to generate robust, highintegrity data that underpins confident clinical decisionmaking.
• 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
• Phoenix WinNonLin®
• SAS®
• SAD / MAD
• Bioavailability / Bioequivalence
• Food effect
• Drug–drug interaction
• Hepatic / renal impairment
• Phase I and Phase II/III PK/PD studies
• Immunology
• Infectious disease
• Cardiovascular
• Rheumatology
• Neurology
• Oncology
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.
Yes — all PK/PD analyses follow high quality GCP based SOPs with independent QC.
Yes — preliminary and interim analyses and dose escalation support are explicitly included.
Yes — hVIVO offers translational modelling & simulation, including preclinical to clinical bridging and starting dose definition.
Phoenix WinNonLin® and SAS®.
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