Overcoming Challenges in Nephrology
Clinical studies in renal diseases present unique challenges. One of the biggest obstacles—identifying and recruiting patients— requires trusted, long-term relationships with sites and key opinion leaders around the world. Driven by external and internal data sources, including our proprietary study management system, ClinTrak®, we leverage our well-profiled network of sites and relationships with PIs and KOLs to determine feasibility and develop a well-vetted recruitment strategy.
The Medpace Advantage for Nephrology & Renal Clinical Trials
Our medical, operations, and regulatory staff understand the complexities of nephrology & renal disease trials from the perspective of the Sponsor, the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. This deep understanding allows us to bring these perspectives to each clinical trial that we conduct to help keep trials running efficiently and according to protocol. In addition to therapeutically specialized, full-service CRO offerings, Medpace provides comprehensive and fully integrated global central lab services, a bioanalytical lab, an imaging core lab, an ECG core lab, and a Phase I unit. The built-in collaboration and efficiencies of working with a single vendor facilitates a streamlined strategy for executing trials of all sizes and scope.
Mapping The Path Across Glomerular Disease Barriers
Nephrology & Renal Disease CRO Capabilities
Medpace has global experience conducting trials for a variety of kidney-related diseases spanning early to late-phase. An international network of nephrology sites and strong relationships with KOLs streamlines the development process and is enhanced by our experience successfully recruiting hard-to-enroll patient populations. We’ve successfully managed Phase III studies through to agency approvals in a variety of indications, including:
- Renal insufficiency and failure
- Genetic or rare kidney diseases including Vasculitis and Enteric Hyperoxaluria
- Glomerulonephritis associated with ANCA vasculitis, IgA nephropathy, membranous nephropathy, C3 glomerulonephritis and focal segmental glomerulosclerosis
- Bone & Mineral Metabolism (including hyperphosphatemia)
- Metabolic acidosis/alkalosis, electrolyte disorders
- Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD) including dialytic therapies
- Diabetic Nephropathy
- Anemia/Chronic Kidney Disease
Our scientifically-driven approach to clinical development provides early and ongoing insight and guidance from therapeutic experts throughout trial design and execution. Understanding that renal patients often have comorbidities such as cardiovascular disease, diabetes, and obesity, our dedicated nephrology and renal disease team frequently works in collaboration with our in-house experts in these associated therapeutic areas. Our model embeds scientific expertise throughout your study, providing greater depth of perspective into these complex and challenging diseases.
Central Laboratories – PD Analysis, Biomarker Assay Development and Validation
Our client’s R&D pipelines are founded on innovation and science. These projects are highly technical by nature and require the experience, reputation and therapeutic knowledge of key opinion leaders. Medpace’s central laboratories have unmatched experience and expertise to seamlessly support nephrology testing. Focused on both the scientific and service aspects with four wholly-owned laboratories in the US, Europe, China, and Singapore, our central lab has the global reach to support studies, assist with regulatory requirements and deliver custom solutions for any need. Our key staff involves doctors, managers, and technologists with considerable expertise in central laboratory operations for the pharmaceutical industry and federally funded programs, from discovery and proof of concept through large, long-term global trials.
Relevant sample areas include:
- Chronic Kidney Disease (CKD)
- Acute Kidney Injury
- Autoimmune Disorders
- Nonalcoholic Steatohepatitis (NASH)
- Endocrine Disorders
Comprehensive Central Laboratory Services
HIGH YIELD CONSIDERATIONS
FOR CLINICAL DEVELOPMENT IN RARE AND GENETIC KIDNEY DISEASES
Bioanalytical Laboratory – PK Analysis
Leveraging state-of-the-art instrumentation, techniques, and facilities, our team of experts at Medpace bioanalytical laboratory has experience in a broad range of small and large molecule bioanalytical and biomarker support. Working in a good laboratory practice (GLP) compliant setting, the bioanalytical laboratory provides method development, transfer, validation, and analysis of preclinical and clinical biological samples.
We have extensive expertise in developing sensitive methods for LC-MS/MS — qualifying multiple-analytes, metabolites, prodrugs, and light- and temperature-sensitive compounds. In addition, our discovery team regularly supports Phase I, FTIH studies which require rapid analysis of PK blood samples, bioavailability, and early toxicology studies.
Core Imaging and Cardiovascular Safety
Given the importance of accessing cardiovascular risk and cardiovascular monitoring in many nephrology and renal disease trials, the Medpace ECG Core Laboratory provides yet another layer of integrated efficiency. Our ECG Core Lab has extensive clinical trial experience with complex CT, MR, US and DXA assessments—and their respective analysis and quality control checks. With highly experienced and knowledgeable leadership by physicians and scientists, Medpace offers significant advantages in experience, systems, data integrity, and compliance.
Medpace Offerings include:
- Board-certified radiologists, nephrologists and endocrinologists demonstrating extensive clinical trial experience needed for safety and efficacy assessments
- Widespread knowledge in qualifying sites with customized and advanced data and acquisition protocols
- Specialized project managers experienced in utilizing these modalities specifically for kidney assessment
- Well-versed team in imaging for endocrine and metabolic clinical trials, closely linked to nephrology studies
- Centralized ECG machines and analysis to provide an electronic cardiac safety database
Expert Cardiovascular Imaging Solutions
Collaborative & Cross-Functional Teams to Execute Your Nephrology Study
Medpace has built a team of medical, clinical, and regulatory experts who have successfully managed and executed nephrology trials encompassing Sponsor/CRO project management and site study coordination from the patient care perspective. All team members are engaged from project initiation to completion, producing truly seamless drug development.
You Benefit From:
- In-house, board certified nephrologists that provide strategic direction for study design and planning, train operational staff, work with Investigators, and provide medical monitoring
- Experienced nurse practitioners, who are fully integrated into your study – supporting our medical and operations team members while providing that additional layer of clinical setting knowledge and insight that will streamline your study
- Seasoned clinical operations staff with specific experience in conducting renal disease trials with a deep understanding of complicated procedures such as effective collection and processing of 24hr urine samples