Clinical Pharmacology Services

End-to-end clinical pharmacology solutions backed by leading expertise in FIH, SAD/MAD, PK/PD, vaccine studies, and specialist patient cohorts to end-to-end  

Our Clinical Pharmacology services deliver end-to-end early phase trial execution—from First in Human to Phase Proof of Concept (PoC)—supported by deep therapeutic expertise, specialist facilities, and a proven track record across complex study designs, and special population cohorts such as renal and hepatic impaired participants

40+ yrs

Early Phase Expertise

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

6

Areas of Specialism

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

120 Beds

Large Clinical Research Units

Large Phase I/II clinical unit, and a dedicated FIH unit totalling (120 beds) and specialist outpatient infrastructure

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ICON_Clinical Pharmacology

Startups

Requiring guidance on regulatory expectations, PK/PD strategy, and adaptive early phase design.

ICON_Human Challenge Trials

Biotech

Needing rapid, high quality early phase evidence to accelerate their development  

Workshop

Pharma

Managing complex dose escalation, interaction, and special population studies at scale and at pace to gain the insights needed to drive decision making.  
ICON_Participants

CROs

Requiring additional sites, or specialist services such as renal and hepatic PK impairment studies, and biosimilar studies to deliver operational expertise driven by deep domain knowledge and experience. 

Study Types

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/Integrated protocols
  • Bioavailability/Bioequivalence (BA/BE)
  • Proof-of-Concept (PoC)
  • Drug–drug and food‑effect studies
  • QT/QTc assessments
  • Vaccine studies
  • Pharmacogenetic
  • Biosimilar
German site _patient in clinic with staff_Copyright by Julia Berlin_RAW__Y6A6377

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 PoC. Enabled by infrastructure, and integrated scientific, laboratory and regulatory support that accelerates high quality trials from FIH through PoC.  

End-to-End Support

Study Design & Consulting

Integrated support with therapeutic specialists, statisticians, PK/PD modelers combined with clinical pharmacologists' design programmes optimised for safety, efficiency and regulatory success. 

Participant Recruitment & Screening

Access to healthy volunteer databases, well characterised patient cohorts and special populations.  

Clinical Execution

Studies conducted in Phase I/II units with pharmacology ready infrastructure—including multifunctional rooms, long stay capacity, and advanced outpatient facilities. And in close proximity to hospitals with ICU departments.  

Bioanalytical & Laboratory Support

Supported by speciality laboratory partners as well as hVIVO laboratories.

Data Analysis, PK/PD & Reporting

Integrated biometry, PK, and medical writing teams provide full-service analysis packages and regulatory aligned documentation.

Regulatory Support

Full support from pre-IND/CTA through to global submissions.

Special Population and Patient Experience

Special Populations

  • Elderly  

  • Pharmacogenetic Normal, Intermediate, Excessive Metabolisers  

  • Gender Trials (female, post-menopausal)   

  • Renal Impairment  

  • Hepatic Impairment  

Patient Populations

  • Diabetic 

  • Obese 

  • Women’s Health (PCO, Endometriosis)  

  • Dermatology (Atopic dermatitis, Psoriasis) 

  • Hypertension  

  • Hypercholesterolemia 

German site_ Patient and Staff Copyright by Julia Berlin_RAW__Y6A6358

Working with hVIVO gives you access to:

Clinical Pharmacology Expertise

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

 Infrastructure 

  • 150+ beds across our German Clinics: Large 94 bed Mannheim clinic; and dedicated renal/hepatic impairment unit in Kiel and our partner site in Berlin.

Our Experience

  • Decades of operational excellence, including 7,700+ participants across 260 trials in Germany alone
  • Strategic scale across UK and EU, enabling robust recruitment, specialised cohorts, and rapid delivery
  • Scientific & Medical leadership in PK/PD, Immunology, Virology, Cardiometabolic and early phase study design
  • Proven FIH–PoC continuity, including integrated SAD/MAD protocols and early patient cohorts enhancing progress of study data to meet clinical and commercial milestones
Mannheim Groupes Action & Building 135

FAQ

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—vaccine trials are conducted across multiple hVIVO sites in the UK and Germany  
Yes—PK, PK/PD, data management, biostats, and medical writing are part of our full-service offering
Yes we have extensive experience with this populations  
Yes depending on the sample size we can deliver this trial type as a single or multi site within our different units.  
 Depending on the patient population and sample size we can deliver PoC trials, we can also act as a site and work with CRO’s.  

Meet our team

hVIVO is led by a dynamic group of experts in their respective fields who are driving excellence throughout the organisation.

Plan your next Clinical Trial with hVIVO

Enquire now