Pediatric Clinical Trials and Clinical Research

Located on the campus of Riley Hospital, the Children's Clinical Research Center (CCRC) is the primary site for most clinical research performed by physician-scientists and clinician investigators at the Child Health Research Institute, the Department of Pediatrics and the Indiana CTSI. This collaboration is the only one of its kind in Indiana, and it is one of the factors that rank us among the nation’s best pediatric departments.

Team

Lucy Miller, RN, BSN — Manager and Senior Clinical Research Staff Leader

The Clinical Translational Research Laboratory (CTRL) is located at Riley Hospital for Children and part of the Child Health Research Institute. The lab provides researchers a means to process and analyze specimens obtained from patients enrolled in clinical studies. Flexible, multi-faceted bench lab space is available for the support needed for specific studies using skilled personnel and state-of-the art equipment, including multiplex analyses for cytokines and other molecular biomarkers, DNA extraction for genotyping and genomics assays, RNA extraction for transcriptomics, ELISA and more. Monitored sample tracking and storage is available at 4 degrees Celsius, -20 degrees Fahrenheit and -80 degrees Fahrenheit. Assistance can also be provided in planning and budgeting for future studies.

Team

Sydney Ross, MS — Laboratory Manager
Lachlan Latz, BS — Laboratory Technician

In a collaboration between the Child Health Research Institute and the Department of Biostatistics and Health Data Science, the DART Biostatistics team provides support for project consultation and design, grant applications, data analysis and results representation for manuscripts and abstracts, and for early-stage investigators.

Team

Laura Zhou, PhD — Faculty Director
James Slaven, MS — Biostatistician
Elisa Sarmiento, MS — Biostatistician

The DART Informatics team provides support for data queries from the EHR (Cerner), starting with project consultation and design, data queries, data cleaning and quality control. The goal is to support Child Health Research Institute investigators with seamless EHR/Cerner data solutions for clinical research.

Team

William Bennett, MD — Faculty Director
Stacy Keller, MSN CPNP — Project Manager
Steven McKee, BS — Manager and Software Engineer
Ashley Mitcham — User Experience Developer
Htaw Htoo, BS — Software Engineer

The goal of the Indiana Biobank is to aid researchers in discovery research that may lead to better ways to treat and prevent diseases. The Indiana Biobank works towards this goal by providing researchers with the tools and resources they need to advance their research.

The Indiana Biobank Pediatrics initiative is based in the Department of Pediatrics and the Child Health Research Institute. Through this collaboration, the biobank provides a core support team that includes a project manager, a laboratory supervisor and lab technician effort for sample processing, aliquoting and biobanking. These samples can be linked to EHR data for use in clinical research by investigators.

Team

Brooke Patz, MA, CCRP — Project Manager
Whitney Jaunzemis, BS, CCRP — Clinical Research Leader
Ashley Mayfield, PhD — Clinical Research Coordinator

The Indiana CTSI Biospecimen Management Core consists of the Specimen Storage Facility and the Clinical and Translational Support Laboratory, which together offer cost-efficient processing and storage services with a focus on consistent quality and sample integrity. The lab offers expertise in processing and shipping human-derived research specimens. Our SOP-driven and protocol specific services ensure compliance with Good Clinical Practices and Good Laboratory Practices.

The Investigational Drug Services (IDS) is part of the IU Health pharmacy department. The IDS supports all clinical trials that require study drugs to be dispensed or administered within Riley Hospital and it provides services including IRB and protocol consultation; operationalizing study protocols; ensuring adherence to IU Health policies and procedures; study drug inventory ordering, maintenance and dispensing; IV drug preparation; drug accountability record maintenance; and order set development. For more information, please visit the IDS page on the IU Office of Clinical Research website.

Team

Melissa Allard, PharmD — Team Lead
Hannah Voss, PharmD
Jessica Wright, CPhT
Bobbie Blair, CPhT