Why DVCR?
Built differently for specialty population studies
A dedicated network built for renal patient access
Our in-house renal expert, Harry Alcorn, PharmD, who serves as the VP of Renal and Hepatic Research, is dedicated to ensuring protocol alignment with the patient population and maintaining close relationships with sites and Principal Investigators (PIs). Few clinical research sites have the expertise and access to recruit and manage renal impairment cohorts across all severity levels including dialysis patients when required, along with healthy matched controls. To address this common bottleneck, we have established strategic partnerships with top-tier, experienced sites and PIs that consistently meet enrollment targets and provide direct access to the appropriate patient population networks helping prevent the delays that often hinder renal programs.
A site-centric model, actively managed
We assign only tenured project managers who have demonstrated success in managing multicenter clinical pharmacology trials and are supported by our in-house renal experts. By closely overseeing study sites, our project managers sustain recruitment efforts and keep milestones on track. This approach offers sponsors a single point of accountability overseeing all operational stages from startup to final deliverables.
Site payments expedited to protect timelines
We accelerate site payments to de-risk study delays and maintain site engagement and study prioritization. When sites are engaged, they recruit faster, which helps protect the study’s timeline and budget, especially when working with a limited patient pool.
Enrollment design that
shortens the timeline
Enrolling healthy controls alongside impaired populations requires a tailored protocol strategy—from 1:1 subject-matching to mean-matching strategies. We work closely with sponsors before protocol finalization to select the optimal design that maximizes data quality while accelerating study completion.
Inclusion and exclusion criteria built with subject matter experts
Unlike healthy volunteers, renal impairment populations require inclusion and exclusion criteria specifically tailored to their complex clinical profiles. Thoroughly evaluating comorbidities, concomitant therapies and clinical status during protocol design is essential. Vetting eligibility parameters with seasoned Principal Investigators before study finalization optimizes recruitment feasibility, safeguards patient safety and ensures robust, timely data collection.
Our approach to renal impairment studies
Our model offers comprehensive CRO services combined with site expertise, so sponsors get end-to-end delivery from one accountable team.
01
Site selection and governance
- Strategically selected site network with proven expertise in renal impairment and direct access to target patient populations
- Established governance charters, clear communication frameworks and defined escalation pathways driven by proactive site partnerships
- Tenured project managers assigned to oversee multicenter execution
02
Protocol and enrollment strategy
- Full or reduced study (for drugs with minor renal elimination) designs per FDA guidance
- Partner with site PIs to refine eligibility criteria, for accelerated enrollment while maintaining rigorous operational objectives of patient safety and quality data
- Utilize sites with established renal networks & databases
- Access to a target patient database supported by experienced PIs and site staff who understand this population with comorbidities and concomitant medications to accelerate screening and enrollment
- Standardized dialysis SOPs across all sites to ensure operational consistency and protocol compliance in ESRD studies
03
Integrated CRO services
- Data management, pharmacokinetics and pharmacodynamics, biostatistics and programming, monitoring, medical writing and central laboratory delivered as one solution
- Active site management to keep recruitment and deliverables on track
- PK analysis and modeling to support dose recommendations
- DVCR Central Laboratory and eClinical ecosystem deliver integrated sample logistics, safety testing, data capture, reconciliation and data review
Site network
Reach and access
- Robust network of sites across North America
- More than 150 PK renal impairment studies conducted across the network in the past five years
- Access to over 350 beds for overnight confinement
- Direct access to comprehensive renal populations, spanning mild, moderate and severe impairment through end-stage renal disease (ESRD) on hemodialysis
Featured study
Challenge
A sponsor required a dedicated renal impairment study evaluating an investigational therapy in participants with varying degrees of renal impairment and matched healthy controls. Successful execution required access to specialized patient populations, experienced sites and coordinated oversight across a multicenter study.
Approach
We applied our site-centric organ impairment model, combining strategic site partnerships, dedicated project management and integrated CRO services to support startup, enrollment and study conduct. Eligibility criteria, enrollment strategy and site oversight were aligned to the unique challenges of recruiting and managing renal impairment populations.
Outcome
The study achieved enrollment and key study milestones ahead of schedule, demonstrating the value of our specialized site network, proactive study management and integrated approach to organ impairment research.
Related resources
Planning a renal impairment study?
Talk to a team with direct access to renal patients.
Whether you are evaluating the need for a dedicated study or choosing a CRO, our team can help you evaluate the best approach to execution, including site selection, enrollment strategy and the network capabilities that make these specialty populations reachable.
