Clinical Research Services
- What We Do
- Tools & Resources
Supporting Excellence in Pediatric Clinical ResearchÌý
Clinical Research Services at Nemours Children’s plays a vital role in fostering high-quality, leading-edge pediatric clinical research studies.Ìý
We provide comprehensive resources, services, and guidance to ensure that clinical research activities are conducted efficiently, ethically, and in compliance with all regulations and institutional policies.Ìý
Our team creates a collaborative environment and works to streamline processes to help researchers achieve their mission to improve children’s health and wellness. Partnering throughout the entire research lifecycle, we’re here from study conceptualization to implementation and dissemination of findings.Ìý
Ensuring High-Quality Clinical Research
Our robust infrastructure includes processes, procedures, and oversight needed for compliant, quality studies that prioritize patient safety and well-being.Ìý
Our team includes clinical research assistants, clinical research navigators, clinical research coordinators, clinical research nurses, clinical trials managers, research quality assurance educators, and regulatory coordinators. Together we support researchers at every step, allowing them to focus on their scientific objectives.Ìý
We provide a wide range of functions and services, including:
- Study feasibility assessments and protocol review
- Regulatory and compliance guidance
- Standard operating procedure development and implementation
- Research education and training programs for study teams
- Access to state-of-the-art Clinical Research Unit facilities and services
- Research participant recruitment and retention support
- Data management and biostatistical support services
- Study monitoring and quality assurance activities
- Funding and grant assistance
- Research collaboration facilitationÌý
- Oversite and review processes through the Medical Council to ensure research integrity and ethical conduct
- Promotion and dissemination of research findings and advancements
Leadership Team
Judith Ross, MD
Director, Clinical ResearchÌý
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Kristen Gibbs, DNP, APRN, CPNP-PC, CCRC
Director, Clinical Research Services
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Melissa HonoreÌý
Program Coordinator
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Kimberly Englert, BSN, RNÌý
Clinical Research Quality Assurance & Education Program Manager
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Kimberly DeylingÌý
Clinical Trials Business Manager
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Clinical Trials & Research Studies at ÐÇ¿Õ´«Ã½
Pediatric clinical trials and research studies are important for advancing medical knowledge and improving care for kids around the world. Our researchers lead clinical research to study new drugs, treatments, devices, and techniques. We also contribute to national registries and collaboratives to further research in many areas. Find a clinical trial or study now.
Providing for the Highest Level of Research
At Nemours Children’s we provide a robust research infrastructure to support industry-sponsored and investigator-initiated clinical trials. Our dedicated resources ensure efficiency, compliance, and high-quality research conduct.Ìý
Clinical Research Units (CRUs)
At the center of our clinical research are state-of-the-art Clinical Research Units in Delaware Valley and Jacksonville, Florida. These state-of-the-art outpatient facilities provide investigators an array of resources and services to support their pediatric clinical studies.
With a specialized environment and experienced staff, researchers can conduct complex, high-impact clinical trials and studies with the highest standards and safety. The unit provides dedicated space and support for pediatric clinical trials, including exam rooms, consultation areas, and workspaces for research teams, and infrastructure for specimen collection, infusions, and monitoring.
Clinical Research Unit, Delaware Valley
Nemours Children’s Hospital, Delaware
1600 Rockland Road
Wilmington, DE 19803
First Floor, next to the Outpatient Laboratory
Clinical Research Center, Jacksonville, FL
Nemours Children's Health, Jacksonville
807 Children's Way
Jacksonville, FL 32207
Ninth Floor, Ambulatory Clinic
Additional Tools & Resources Ìý
We invest in a full range of technologies, programs, and resources for clinicial investigators. These include:
Clinical Trial Management System (CTMS)
We are implementing Verily to digitally integrate and manage protocols, documents, and study data, provide real-time oversight and reporting across all research sites, and reduce administrative burden and improve research efficiency.
E-Florence eRegulatory System
Our teams have access to Florence eRegulatory to streamline regulatory document management. This HIPAA- and FDA 21 CFR Part 11-compliant system centralizes study documentation in a secure electronic format, allows for remote monitoring and electronic signatures, and reduces compliance risks and administrative workload.
Institutional Review Boards (IRBs)
ÐÇ¿Õ´«Ã½ operates two Institutional Review Boards (IRB)Ìýto oversee the ethical conduct of human subjects research. Our IRBs ensure compliance with federal and state research regulations, include multidisciplinary experts and community representatives, and support collaboration with external IRBs, as needed.
Data Management Plan (DMP) Tool
Our researchers can create and manage their Data Management and Sharing Plans (DMPs) using the DMPTool, which provides structured templates for compliance with federal funding requirements and facilitates secure data sharing and research transparency.
Investigational Drug Services (IDS)
Our research pharmacy network supports clinical trials involving investigational products. These services include secure storage, dispensing, and monitoring of investigational drugs, temperature-controlled inventory management, and coordination with study monitors and regulatory compliance support.
Clinical Trials Business Office
We help investigators navigate the financial and contractual steps of industry-sponsored clinical trials. From submitting an Intent to Pursue through budget development, coverage analysis, and contract negotiation, we ensure everything aligns with study goals and compliance standards. Once a trial is active, we coordinate invoicing, account setup, and provide ongoing financial oversight to keep things running smoothly.
Investigational Drug & Device Committee
We support investigators conducting pediatric research involving investigational drugs or devices. The committee offers expert guidance on protocol development, regulatory requirements, and FDA submission processes for investigator-initiated studies.Ìý
Office of Technology Transfer
The Office of Technology Transfer helps investigators manage intellectual property, establish clinical trial agreements with industry partners, and explore licensing or commercialization opportunities for pediatric innovations.
Research Quality Assurance (RQA) Program
The RQA program promotes excellence in clinical research by conducting quality monitoring and study audits, offering training and education for research teams, and ensuring adherence to federal regulations and Good Clinical Practice.