Conducting Research at Cincinnati Children's
Reasons to Partner with Us
Our Research Study Credentials
Clinical Research Staff
- Experienced investigators for sponsor clinical trials
- 500 Cincinnati Children's/University of Cincinnati College of Medicine investigators
- All major pediatric medical and surgical subspecialties offered
- Expert faculty and staff for protocol/product consultation
- Research pharmacists experienced with investigational drugs
- More than 200 experienced study coordinators
- Certified study coordinators: Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SoCRA)
Study Planning
- Knowledgeable in study design to meet the needs of investigators and sponsors
Contract/Budget
- Experience in creating and negotiating contracts and budgets
Quality Protocol Conduct
- Compliance with Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and Code of Federal Regulations (CFR) requirements for Good Clinical Practice (GCP) study conduct
- On-site IRB with weekly scheduled meetings
- Experienced regulatory affairs coordinator to maintain regulatory documents both during and after study completion
- Standard Operating Procedures (SOPs) consistent with regulatory requirements
- Investigator and coordinator training in GCP and research study management with CEU and CME credits
- In-house compliance quality review (audits) of ongoing studies
- Centralized scheduling of principal investigator meetings, site assessment and initiation meetings, and study monitoring visits
- Study report - preparation and submission
Participant Identification and Recruitment
- Full-time, experienced participant recruiters working with a full-complement of Cincinnati Children's marketing and public relations staff
- Access to large, diverse pediatric and adult populations throughout the region, including Southwestern Ohio, Southeastern Indiana and Northern Kentucky
- Volunteer and past study participant database
Research Facilities
- 1,000,000 square feet of research and office space to support expanding academic programs
- Extensive clinical and academic research facilities
- Comprehensive on-site laboratories
- Central Laboratory
- Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management
- Laboratory for Specialized Clinical Studies
- Mass Spectrometry Laboratory
On-site investigational pharmacies Monitor rooms, pediatric- and adult-friendly participant exam/treatment rooms and waiting areas Convenient parkingData Management and Reports
- Ethically-produced, high-quality, clinical and research data
- Report and manuscript writing submission and publication
Cincinnati Children's Research Foundation Therapeutic Study Areas
Pediatric Therapeutic Areas
- Allergies
- Aerodigestive Disorders
- ALS
- Arthrogryposis
- Asthma
- Attention Deficit Hyperactivity Disorder
- Autism
- Blood and Marrow Transplantation
- Bone Formation Disorders
- Brachial Plexus Injuries
- Brain Tumor
- Bronchitis
- Cardiac Transplantation
- Cardiovascular Disorders and Malformations
- Cerebral Palsy
- Congenital Cardiac Malformations
- Congenital Diaphragmatic Hernia
- Congenital Lung Malformations
- Connective Tissue/Skeletal Dysplasias - Marfan Syndrome/Ehlers Danlos Syndrome
- Cystic Fibrosis
- Diabetes Mellitus
- Down Syndrome
- Dual Diagnosis of Developmental Disability/Mental Health Disorder
- Dyspraxia
- Eosinophilic Disorders
- Epilepsy
- Esophageal Disorders
- Facial Plastic Reconstruction
- Fanconi Anemia
- Food Allergies
- Gastrointestinal Diseases
- Gaucher Disease
- Goiter
- Growth Disorders
- Headache Disorders
- Head and Neck Disorders
- Head Trauma
- Hemangioma and Vascular Malformation
- Hematologic Disorders
- Hemophilia
- Hereditary Cancer
- Hirsutism
- Histiocytosis
- Hypertension
- Hypoglycemia
- Immotile Cilia Syndrome
- Immunodeficiencies
- Inflammatory Bowel Disease
- Intestine Transplantation
- Juvenile Rheumatoid Arthritis
- Kidney Disease
- Kidney Transplantation
- Laryngeal Disorders
- Learning Disabilities
- Leukemia
- Liver Disease
- Liver Transplantation
- Lupus
- Lysosomal Disease
- Mental Retardation
- Metabolic Disorders
- Motility Disturbances
- Multiple Anomalies
- Muscular Dystrophy
- Myelomeningocele
- Neurological Diseases
- Neuromuscular Diseases
- Obesity
- Obssessive Compulsive Disorder
- Opthalmic Diseases
- Otitis Media
- Pain Management
- Pervasive Developmental Disorders
- Pediatric Trauma
- Pneumonia
- Psychiatric Disorders
- Psychological and Behavioral Disorders
- Pulmonary Hemosiderosis
- Rhinitis
- Rubinstein-Taybi Syndrome
- Seizure Disorders
- Sexual Development Disorders
- Short Gut Syndrome
- Sickle Cell Anemia
- Sinusitis
- Skin and Soft Tissue Disorders
- Sleep Disorders
- Small Bowel Transplantation
- Speech Disorders
- Spina Bifida
- Sports Injuries, Care, Prevention and Performance training
- Stroke
- Thyroid Disorders
- Tonsillitis
- Tourette Syndrome
- Trauma Medicine
- Tuberous Sclerosis
- Turner Syndrome
- Urologic Problems
- Velopharyngeal Dysfunction
- Voiding Dysfunction
Adult Therapeutic Areas
- Adult Genetic Disorders - Hemochromatosis, Hypercholesterolemia and Polycystic Kidney Disease
Cincinnati Children's Research Foundation Clinical Trials Expertise
Major clinical trials expertise including:
- Acute Pain Service
- Adult Genetics Clinic
- Aerodigestive and Sleep Center Allergy Clinic
- Attention Deficit Hyperactivity Disorder
- Blood Disease Center
- Brachial Plexus Center
- Cancer Center
- Cardiac Intensive Care Unit
- Catheterization and Interventional Cardiology
- Center for Infants and Children with Special Needs
- Central Venous Catheter Program
- Cerebral Palsy Clinic
- Child Abuse Team / Mayerson Center
- Chronic Ventilation Program
- Clinic for Systemic Lupus Erythematosus
- Clinical Neuropharmacology Laboratory
- Cochlear Implant Program
- Comprehensive Weight Management Center
- Congenital Diaphragmatic Hernia Team
- Connective Tissue / Skeletal Dysplasias Clinic
- Craniofacial Center
- Cystic Fibrosis Clinic
- Developmental Assessment for Infants / Toddlers
- Diabetes Center
- Dialysis Unit
- Electrophysiology
- End-Stage Renal Disease Care Program
- Enteral Access Clinic
- Eosinophilic Disorders
- Epidermolysis Bullosa (EB) Center
- Epilepsy Program
- Feeding Team
- Fetal Care Center of Cincinnati
- Food Allergy Clinic
- Gaucher Disease Treatment Center
- Genetics Outreach Clinics
- Growth Disorders
- Headache Center
- Hearing and Deafness Research Center
- Heart Center
- Heart Transplant
- Hemangioma and Vascular Malformation Center
- Hereditary Cancer Program
- High-Risk Infant Follow-up Clinic
- Hip Deformity Service
- Human Genetics Metabolic Diseases Clinic
- Hypertension Clinic
- Immunodeficiencies and Histiocytosis Program
- Inflammatory Bowel Disease Center
- Inpatient Rehabilitation
- Interventional Radiology
- JRA Affected Sib-Pairs Registry
- Juvenile Arthritis Special Treatment Center
- Kelly O'Leary Center for Autism Spectrum Disorders
- Kidney Clinic/Institute/Transplant Program
- Lactation Education Resource Center
- Liver Care Center
- Lysosomal Disease Center
- Marfan / Ehlers Danlos Syndrome Clinic
- Molecular and Genetic Cardiology
- Molecular Genetics Laboratory Services
- Movement Disorder Clinic
- Myelomeningocele Clinic
- Neurobehavioral Clinic
- Neurometabolic Program
- Neuromuscular Program
- Neuropsychological Evaluation
- New Onset Seizure Clinic
- Outpatient Centers
- Pain Management Clinic
- Plastic Surgery Clinic
- Preventative Cardiology
- Process Improvement and Outcomes Research
- Psychiatric Intake Response Center
- Regional Center for Newborn Intensive Care (RCNIC)
- Rubinstein-Taybi Syndrome Program
- Skin Sciences Institute
- Sleep Disorders Center
- Smoking Cessation
- Sports Medicine Biodynamics Center
- StarShine Hospice
- Teen Health Center
- Tourette Syndrome Clinic
- Translational Research Trials Office
- Trauma Services
- Tuberous Sclerosis Program
- Turner Syndrome Clinic
- Vaccine Trial and Evaluation Unit
- Velopharyngeal Dysfunction Clinic
- Voiding Dysfunction Center
- Youth Shyness Program
Cincinnati Children's Demographics
Cincinnati Children's recruits pediatric and adult subjects from the Greater Cincinnati area including eight counties. As Greater Cincinnati's only pediatric hospital, Cincinnati Children's serves one of every four families in Southwestern Ohio, Southeastern Indiana and Northern Kentucky. Cincinnati Children's patient racial profile includes 19.1% African-American, 0.1% American Indian/Alaska native, 0.8% Asian, 59.7% Caucasian, 1.3% Hispanic, 2.0% multiracial and 16.9% other. Cincinnati Children's cares for patients from most of the 50 states and countries around the world with 917,204 patient encounters every year.
Cincinnati Children's Hospital Medical Center is a 475-bed medical center comprising:
- Cincinnati Children's Hospital
- Cincinnati Children's Research Foundation
- Teen Health Center of Greater Cincinnati
- Children's Dental Care Foundation
- Cincinnati Center for Developmental Disorders
- Convalescent Hospital for Children
- United Cerebral Palsy, Inc.; Aaron W. Perlman Center for Children
Admissions (FY 2007)
- Admissions (including short stays): 16,645
- Short stay visits: 10,159
- Emergency Department visits: 93,416
- Beds in service: 475
- Patient encounters: 917,204
Outpatient visits (FY 2007)
- Outpatient visits (including surgery and urgent care): 783,043
Surgical Procedures (FY 2007)
- Inpatient: 5,892
- Outpatient (includes satelites): 23,069
Transplants (FY 2007)
- Stem cell: 72
- Heart: 4
- Liver: 21
- Kidney: 18
- Small Bowel: 0
- Multi-visceral: 6
CTO Location
The CTO resides in the CCCR located on the Oak Campus of Cincinnati Children's Hospital Medical Center. The medical center is located approximately three miles from downtown Cincinnati and about sixteen miles (25 minutes) from the Greater Cincinnati/Northern Kentucky International Airport. Cincinnati Children's is in close proximity to comfortable accommodations within a five-block area, as well as a short distance from downtown Cincinnati hotels.
Initiating NIH/Industry Protocols at Cincinnati Children's
Cincinnati Children's participates in pediatric Phase I-IV trials as well as outcomes and epidemiological research. Select adult research trials, Phase I-IV, are also conducted in the CCCR facility. If you are interested in conducting a clinical trial here, please contact:
Mark Schuller
Marketing and Recruiting Manager
Clinical Trials Office
Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue, MLC 7004
Cincinnati, Ohio 45229-3039
Phone: (513) 636-0314
Fax: (513) 636-0168
E-mail: mark.schuller@cchmc.org
