Clinical Research Services

What We Do
Tools & Resources

Supporting Excellence in Pediatric Clinical Research

Clinical Research Services at Nemours Children’s plays a vital role in fostering high-quality, leading-edge pediatric clinical research studies.

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.

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.

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.

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.

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 facilitation
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 Research

Learn More About Dr. Ross

Kristen Gibbs, DNP, APRN, CPNP-PC, CCRC

Director, Clinical Research Services

Melissa Honore

Program Coordinator

Kimberly Englert, BSN, RN

Clinical Research Quality Assurance & Education Program Manager

Kimberly Deyling

Clinical Trials Business Manager

Clinical Trials & Research Studies at Nemours

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.

Find a Clinical Trial

Providing for the Highest Level of Research

Two children making a heart with their hands.

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.

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

de-cru@nemours.org

Clinical Research Center, Jacksonville, FL

Nemours Children's Health, Jacksonville
807 Children's Way
Jacksonville, FL 32207

Ninth Floor, Ambulatory Clinic

Additional Tools & Resources

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)

Nemours operates two Institutional Review Boards (IRB) to 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.

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.

OUR RESEARCH

IMPACT & AWARDS

LEADERSHIP & OVERSIGHT

INFRASTRUCTURE & SUPPORT

ADMINISTRATIVE SERVICES

Clinical Research Services

Supporting Excellence in Pediatric Clinical Research

Ensuring High-Quality Clinical Research

Leadership Team