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Clinical Pharmacology

hVIVO accelerates development via Phase I clinics, human challenge models, biometrics, medical monitoring, and Phase II/III sites across UK & Germany. 
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Expertise

40+ years of early phase expertise 

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Experience

Extensive experience across indications; immunology, infectious diseases, dermatology, women’s health, cardiometabolic disorders, renal and hepatic impairment studies

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Capability

Proven capability running complex FIH studies with integrated SAD/MAD/food effect designs in a single cohesive protocol

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Scale

Large Phase I/II clinical units (120 beds) and specialist outpatient infrastructure.

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What is Clinical Pharmacology?

Our Clinical Pharmacology service provides scientifically rigorous, operationally robust and agile early‑phase clinical trials spanning: 

  • First‑in‑Human (FIH)
  • Single/Multiple Ascending Dose (SAD/MAD) including umbrella protocols
  • Bioavailability/Bioequivalence (BA/BE)
  • Drug–drug and food‑effect studies
  • QT/QTc assessments
  • Vaccine studies
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We Support Stuff

Start up

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Biotech

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Pharma

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CRO

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Working with hVIVO

Working with hVIVO gives you seamless access to deep clinical pharmacology expertise, specialised early phase infrastructure, and integrated scientific, laboratory and regulatory support that accelerates high quality trials from FIH through Phase II.
Meet the Clinical Pharmacology experts
  1. Study Design & Consulting
    Therapeutic specialists, statisticians, PK/PD modellers and medical leads design programmes optimised for safety, efficiency and regulatory success. 

  2. Participant Recruitment & Screening
    Access to healthy volunteer databases, well characterised patient cohorts in respiratory diseases such as asthma and COPD as well as in cardiometabolic diseases such MAFLD, Diabetes and Cardiovascular, and specialist populations including renal/hepatic impairment. 

  3. Clinical Execution
    Studies conducted in Phase I/II units with pharmacology ready infrastructure—including multifunctional rooms, long stay capacity, and advanced outpatient facilities. 

  4. Bioanalytical & Laboratory Support
    Supported by hVIVO’s accredited virology, immunology, molecular biology, and biomarker labs 

  5. Data Analysis, PK/PD & Reporting
    Integrated biometry, PK, and medical writing teams provide full service analysis packages and regulatory aligned documentation.

  6. Regulatory Support
    Full support from preIND/CTA through global submissions.

hVIVO gives you access to:

Clinical Expertise

  • FIH trial leadership across small molecules, biologics, biosimilars, mRNA, siRNA, and vaccines.
  • Experience in dermatology, women’s health, endocrinology, cardiometabolic 
disease, nephrology, gastroenterology, immunology & metabolic disorders.

Infrastructure

  • 120+ beds across our German Clinics: Large 94bed Mannheim clinic; dedicated renal/hepatic impairment unit in Kiel.
  • Integrated human challenge expertise via purpose built containment level 3 challenge unit.  
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Case Studies

Case Study

A New Frontier in Respiratory Health: Next-Gen Human Challenges Explained

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A New Frontier in Respiratory Health: Next-Gen Human Challenges Explained

Case Study

Beyond Traditional Studies: The New Era of Respiratory Virus Human Challenge Models

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Beyond Traditional Studies: The New Era of Respiratory Virus Human Challenge Models

Scientific Publication

The Future of Virology: How Next-Gen Human Challenge Models are Breaking Barriers

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The Future of Virology: How Next-Gen Human Challenge Models are Breaking Barriers

Scientific Publication

Refining Viral Pathogenesis Studies via Advanced Human Challenge Frameworks

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Refining Viral Pathogenesis Studies via Advanced Human Challenge Frameworks

Case Study

Advancing Respiratory Virus Research Through Next‑Generation Human Challenge Models

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Advancing Respiratory Virus Research Through Next‑Generation Human Challenge Models

    FAQ

    Still have questions?
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    Get in touch with us

    Yes — our teams manage both HV and special populations including renal/hepatic impairment, elderly cohorts, and women specific studies.

    Yes — our teams manage both HV and special populations including renal/hepatic impairment, elderly cohorts, and women specific studies.
    Yes — our teams manage both HV and special populations including renal/hepatic impairment, elderly cohorts, and women specific studies.
    Yes — our teams manage both HV and special populations including renal/hepatic impairment, elderly cohorts, and women specific studies.
    Can you run integrated protocols incorporating healthy volunteers and patient populations?  
    Can you run integrated protocols incorporating healthy volunteers and patient populations?  
    Do you offer integrated PK/PD modelling?
    Can you run integrated protocols incorporating healthy volunteers and patient populations?  
    Do you offer integrated PK/PD modelling?

    Meet Our Experts

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    Plan your next Clinical Trial with hVIVO

    If you're a potential customer, find out how hVIVO can help you.