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Hepatic Impairment

A specialty site network that has conducted more than 150 hepatic impairment studies in the past five years.

Discuss your hepatic impairment study
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Hepatic impairment studies, past five years

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Combined impairment studies

Why DVCR?

Built differently for hepatic impairment studies

Patient access that keeps
hepatic studies moving

Conducting hepatic impairment trials requires a specific strategy for either full or reduced study designs. These protocols rely on matching healthy control subjects with patient cohorts categorized by Child-Pugh scores, with full designs including mild, moderate and severe impairment, and reduced designs including only moderate impairment. 

Given the global scarcity of sites with the specialized databases and referral networks required to recruit these populations, enrollment often stalls. We solve this challenge through a site-centric model, partnering with high-performing sites/PIs and staff who understand hepatic patients and have the experience to ensure predictable execution.

Bringing sites, experts and
CRO services together

Our in-house hepatic experts work together on protocol design from the start, ensuring inclusion criteria are practical and match patient population trends to optimize recruitment. Paired with our comprehensive CRO services, we manage every detail—from protocol development to final deliverable within a single organization. This integrated approach ensures predictable enrollment and timely milestone delivery without the friction or handoff gaps of a multi-vendor model.

Tenured project managers
who know the population

We assign project managers who specialize in complex clinical pharmacology trials and bring extensive experience leading multicenter studies. This depth of expertise is vital in hepatic trials, where patients frequently present with underlying comorbidities and extensive concomitant medication lists that can complicate eligibility and enrollment.

Site payments expedited
to keep studies moving

Our model accelerates site payments to de-risk study delays and keep sites engaged and committed to the study. Engaged sites prioritize recruitment, which protects the study timeline, especially when working with a hard-to-identify patient population.

Eligibility criteria designed
for the hepatic population

Aligning inclusion and exclusion criteria with real-world patient profiles is fundamental to study success. By proactively addressing common comorbidities and concomitant medication requirements during protocol design, we eliminate major recruitment barriers. Furthermore, our experienced investigators work directly with treating physicians to guide safe, protocol-compliant medication management—enabling eligible patients to screen successfully and maintain study compliance. Ultimately, a protocol tailored to the actual patient population drives significantly faster enrollment than one based on standard criteria.

Our approach to hepatic impairment studies

Our integrated model combines specialized operational and scientific expertise in hepatic impairment with active site management—streamlining patient recruitment and retention to eliminate mid-study operational burdens for sponsors.

01

Site selection and governance

  • Strategic site network and subject matter experts with proven hepatic impairment experience and direct access to target patient populations
  • A site-centric model with hands-on management of partner sites 
  • Tenured project managers assigned to oversee multicenter execution
02

Study design support

  • Single-dose or multiple-dose designs supported, matched to the drug’s PK profile 
  • Full and reduced Child-Pugh designs, with control subjects matched  
  • Eligibility criteria developed with site patient data for common comorbidities and concomitant medications without sacrificing study objectives
03

Integrated CRO services

  • CRO services from protocol development to final CSR  
  • Active site management to protect enrollment and milestones 
  • PK analysis to support dose and dosing-interval recommendations 
  • Central Laboratory and eClinical ecosystem delivers integrated sample logistics, safety testing, data capture, reconciliation and data review

Site network

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Reach and access

  • High-performing sites with a proven track record of successfully executing complex hepatic impairment studies
  • Specialized sites leveraging proprietary hepatic patient registries, extensive specialist referral networks and data-driven recruitment strategies to optimize enrollment 
  • Specialized site staff proficient in evaluating hepatic impairment, comorbid conditions and conmedications to accelerate recruitment while minimizing screen failures
  • A collaborative site network that shares operational insights and recruitment best practices to reduce overall study timelines and costs

Related resources

Planning a hepatic impairment study?

Talk to a team with direct access
to hepatic patients.

Whether you are weighing a full versus reduced design or choosing a CRO, our team can help you evaluate the best approach to execution, including site selection, eligibility strategy and the network capabilities that make these specialty populations reachable.

Discuss your hepatic impairment study Renal and Hepatic Impairment Studies info Sheet