Renal & Hepatic

 Renal and Hepatic Impairment Studies & PK Expertise at hVIVO  
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Mannheim Groupes Action & Building 121

Centre of Excellence

hVIVO Kiel is a dedicated Centre of Excellence for renal and hepatic impairment clinical pharmacology. Established in 1994, the site is a fit-for-purpose  facility associated with the University Hospital Kiel and Lübeck. With more than 220 clinical trials and over 2,100 patients enrolled since 2005, the site delivers deep therapeutic and operational expertise in impairment studies.
Mannheim Groupes Action & Building 131

Specialists in Renal and Hepatic Impairment


  • Fit‑for‑purpose 26‑bed facility
  • 24/7 access to University Hospital Kiel
  • Multi‑channel recruitment & strong physician network
  • Expertise across renal & hepatic impairment (all severity groups)
  • Proven rapid recruitment in single‑ and multi‑centre studies
  • 11 PK analysts + 10 consultants
  • Interim PK results within 5 working days
  • Independent monitoring & continuous safety oversight

Renal & Hepatic Expertise

Clinical & Safety Monitoring

The unit maintains 24/7 access to University Hospital Kiel, providing continuous medical support. Independent clinical monitoring, frequent life-support training, and double-check workflows for lab data ensure robust safety oversight. Medical Monitors conduct ongoing AE/SAE reviews, protocol assessments, eligibility checks, and monthly eCRF evaluations.

Recruitment Strategy

hVIVO Kiel benefits from strong clinical infrastructure and referral pathways, being directly associated with the University Hospital Kiel and Lübeck, supported by an extensive network of hepatology and nephrology practices, and having access to the hospital’s dialysis facility. These partnerships are complemented by a dedicated patient database for individuals with hepatic and renal insufficiency, enabling efficient identification and recruitment of suitable participants for impairment studies.

Pharmacokinetic Expertise

The pharmacokinetic team includes 11 PK analysts and 10 consultants performing over 150 PK/PD analyses each year. Analyses utilise Phoenix WinNonlin and SAS, enabling efficient processing, interim analyses, and rapid go/no-go decision support. Intermediate PK data can be delivered within five working days after receiving bioanalytical data.

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Who We Work With: Renal & Hepatic Impairment Trials

Pharmaceutical

We work with pharmaceutical companies who require renal and hepatic impairment studies. This is typically requested later in the drug development timeline around Phase II/III. 

Clinical Research Organisations

We support CRO's who are required to run renal and hepatic impairment studies on behalf of sponsors. 

ICON_Renal & Hepatic Impairment

Case Study Renal Impairment

Our site successfully recruited and matched renal impairment patients across severity groups within short timelines.

Key success factors included a strong physician network, efficient bed planning within the 26-bed facility, and the ability to support multiple parallel trials.

ICON_Hepatic

Case Study Hepatic Impairment

In a multi-centre study across Germany and South Korea, hVIVO Kiel coordinated closely with international partners to achieve efficient recruitment. The site demonstrated flexibility by preparing control subjects for rapid dosing and being ready to exceed planned recruitment targets.

Meet our team

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

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FAQ

Renal & Hepatic 
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The site specialises in renal and hepatic impairment populations across severity levels, with strong pre-selection and referral pathways.

 Recruitment timelines are accelerated through strategic matching, extensive physician networks, and a robust database of more than 37,000 individuals 

There is 24/7 medical oversight, continuous AE/SAE monitoring, structured stopping rules, and close collaboration with the University Hospital Kiel.

 

 Yes. The PK team produces high-quality interim and full analyses using industry-standard software, supporting dose decisions and regulatory submissions. 

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