Overview

Loma Linda University has a number of affiliated entities which include the Loma Linda University Medical Center, Loma Linda University Children’s Hospital, Loma Linda University Medical Center East Campus, Behavioral Medicine Center, Heart and Surgical Hospital, Loma Linda University Medical Center-Murrieta and Loma Linda University Beaumont-Banning. These entities serve as the teaching facilities for the University’s eight schools. Loma Linda University Medical Center operates some of the largest clinical programs in the United States in areas such as neonatal care and outpatient surgery and is recognized as the international leader in infant heart transplantation and proton treatments for cancer. The institution has approximately 1.7 million patient visits annually. LLUMC is the only level one trauma center for Inyo, Mono, Riverside and San Bernardino counties which covers an area of 2 million residents.

The Loma Linda University Health Clinical Trial Center (CTC) provides centralized support for Loma Linda University Health (LLUH) clinical investigators and departments with a focus on industry sponsored clinical trials with a mission to facilitate the timely execution of quality clinical trials. Operating as a centralized logistics office with the highest level of efficiency and customer service, the CTC also promotes clinical trial quality and development through consultation, training and the pursuit of new trial opportunities. For Sponsors the CTC is a one-stop resource for companies committed to the highest quality clinical studies. The CTC provides sponsors with access to experienced clinical investigators and experienced study coordinators, as well as a full spectrum of support services.

Services include:

• Feasibility Analysis
• Budget development and negotiation
• Medicare Coverage Analysis
• Ancillary support and billing facilitation
• Financial Management
• Regulatory management
• Study advertisement and recruitment
• Coordinate administrative needs among LLUH research stakeholders
• Marketing and liaison services with external sponsors
• Clinical trial education

Experience

Notable Research Discoveries

Currently, there are almost 300 clinical studies being conducted with over 1600 subjects enrolled in the studies. The innovations created at Loma Linda University have changed countless lives. A partial list of research achievements at Loma Linda University that brought significant change to the world in which we live:

• First Infant Heart Transplant
• First Hospital-Based Proton Accelerator for Cancer Treatment
• Pioneering Pain Control in Dentistry
• Pioneering Coronary Angiography
• Treatment of Prostate Cancer
• Studies of Fetal Development
• Treatment of Congenital Hand Deformities
• A Method of Monitoring Blood Clotting that Improves Open Heart Surgery

Areas of Clinical Research

• Cancer - Brain, Breast, Gastrointestinal, Genitourinary, Gynecologic, Lung, Lymphoma, Soft Tissue Sarcoma
• Pediatrics - Autism, Tuberous Sclerosis, Muscular Dystrophy, Epilepsy, Cardiology, Diabetes, Neurology, Gastroenterology, General Pediatrics, Nephrology, Allergy, Pulmonology, Cystic Fibrosis, Multiple Sclerosis, Seizure Disorder, ADHD (Attention Deficit Hyperactivity Disorder), Critical Care
• Neurology - Seizure, Neuropathy, ALS, Neuromuscular disorders, Parkinson's Disease, PSP, Multiple System Atrophy, Dystonia, Spasticity, Movement Disorders
• Cardiology - Heart Failure, Electrophysiology
• Cardiothoracic Surgery
• General Surgery
• Trauma Services
• Ophthalmology
• Rheumatology - Psoriatic Arthritis, Rheumatoid Arthritis, Lupus, Scleroderma/Systemic Sclerosis
• Pulmonary, Critical Care, Hyperbaric and Sleep Medicine - Sleep Disorders, Sepsis, Critical Care, Hemodynamic Monitoring, Pulmonary Hypertension, COPD, Asthma, Resuscitation, Bronchoscopy, Interventional Pulmonology, Pleural Disease
• Dermatology - Psoriasis, Acne Vulgaris, Skin Cancer, Melasma/Hyperpigmentation in skin color, Atopic Dermatitis, Skin of Color, Alopecia, Pediatric Vascular Skin Lesions and Birthmarks, Antifungals
• Urology
• Maternal/Fetal - High Risk Pregnancy, Neonatal
• Gynecology and Urogynecology
• Other Areas - Osteoporosis, Acute Kidney Injury, Apheresis, Liver Disease, Inflammatory Bowel Disease, and more!

Sponsors with whom we have worked

Facility

Loma Linda University Health is comprised of the following entities:

Loma Linda University Medical Center

• 371 beds
• Houses the only Level I Trauma Center in a four-county area (two million residents)

Loma Linda University Children's Hospital

• 343 beds
• 84 NICU beds (one of the largest in the country)

Loma Linda University Medical Center East Campus

• 134 Beds
• Urgent Care (over 30,000 visits annually)

Behavioral Medicine Center

• 89 beds
• Serving adults, seniors, adolescents and children (only facility in San Bernardino and Riverside Counties serving children 4-13 years old)

Surgical Hospital

• 28 inpatient beds, 6 operating rooms, 2 cath lab suites, 2 special procedure rooms, MRI, Ultrasound, CT scanner

Loma Linda University Beaumont-Banning

• Primary Care, Outpatient Rehabilitation, Pharmacy, Surgery Center, Laboratory Services, Urgent Care

Loma Linda University Medical Center - Murrieta

• 112 Beds (including 12 ICU Beds and 6 NICU beds)

Other

Clinical Research Expertise

IDS Pharmacy – Investigational Drug Services provided through the Loma Linda University Medical Center Department of Pharmacy and offers inpatient and outpatient study drug management.

Original Medical Records/Source Documentations/CRFs – Medical Experience with hard copy and electronic CRF’s. Electronic medical records utilized: 21 CFR Electronic Medical Record. Protected EMR work queue provided for monitoring.

Monitor Visit Facilitation – Designated monitoring space provided. Internet access, phone, fax, and copies available in research office and at the department level.

Research Consulting Group – Study Design and Biostatic Analysis

Research Education and Training – Biohazardous Materials, Hazardous Waste Shipping, Good Clinical Practice, IATA Training and Certification, NIH Training, CITI Training, Monthly Coordinator Networking with CEUs available.