Overview

Bernstein Clinical Research Center (BCRC) has been conducting clinical research studies since 1969. Our center has conducted more than 700 clinical trials in adult and pediatric patients, and we have contributed to the development of new therapies for asthma, allergic rhinitis and chronic obstructive pulmonary disease (COPD). Our center has also conducted nonrespiratory clinical trials for dermatological disorders (e.g., urticaria, hereditary angioedema, atopic dermatitis), migraines, hypertension and gastroesophageal reflux disease.

Our physician investigators are board-certified internists and allergists/immunologists and serve on the faculty of the Division of Allergy/Immunology at the University of Cincinnati. They have published hundreds of clinical research articles in peer-reviewed journals and are invited to speak at national and international medical meetings. Our physician investigators are certified in clinical research.

Our dedicated clinical research staff is highly trained and experienced. Our center has three CCRCs. All coordinators and investigators have completed the CITI training program from the University of Cincinnati. The study research team includes a nurse practitioner, a former critical care nurse, a registered respiratory therapist and other well-trained clinical research professionals.

Research Experience

BCRC conducts phase 1 to 4 clinical trials for many large and small pharmaceutical companies. Our clinical research center has gained a reputation for excellence providing and maintaining comprehensive source documents, timely completion of case report forms and has consistently achieved randomization goals with qualified subjects. Due to rigorous and careful screening, our center has enjoyed high completion rates with minimal numbers of screen failures. We have successfully completed many sponsor and FDA audits.

Respiratory Clinical Trials

• Pulmonary function equipment
• Exercise-induced asthma challenge equipment and room
• Specialized methacholine and challenge testing
• Fractional expired nitric oxide test (ENO)
• NIOSH-approved instructor
• Sputum collection
• Overnight facility for asthma and COPD trials

Facility Description

BCRC’s facility meets all regulatory requirements of ICH/GCP and FDA. Our staff is IATA-certified for lab shipment. The facility includes

• 6,000 sq. ft. state-of-the-art facility equipped to do phase 1 to 4 clinical trials;
• Phase 1 unit (16 beds);
• Private rooms for conducting the informed consent process;
• Three locked and secure drug storage facilities equipped with a refrigerator and -40° freezer;
• Onsite, locked archiving storage facility;
• Private study/interview/exam/patient rooms;
• Comfortable and well-equipped patient lounge for extended visits (12-hour);
• Private space for monitors and audits;
• Dedicated and secure space for research staff;
• Skin testing rooms;
• Laboratory specimen processing area, refrigerated centrifuge, -80°C freezer;
• Electrocardiogram equipment and experience with Holter monitoring;
• Chest X-ray and processing equipment;
• Stadiometer (pediatric trials);
• Wireless internet and modem;
• Access to copiers, fax machines and telephones;
• Rigorous OSHA requirements and training for all clinical research staff;
• Detailed SOPs and job descriptions for clinical research staff; and

• Crash cart and defibrillator equipment.

Investigator Experience

David I. Bernstein, MD, FACP, CCI

Dr. David Bernstein is a professor of clinical medicine at the University of Cincinnati School of Medicine in Cincinnati, Ohio, and is a DIA-certified investigator. He is also director of the allergy diagnostic laboratory in the Division of Immunology and director of the university hospital allergy clinic. He is also co-director of the allergy research laboratory and the allergy and immunology fellowship training program.

Dr. Bernstein earned his medical degree from the University of Cincinnati College of Medicine and completed his residency in internal medicine at the Cleveland Clinic Hospital. He then received training in allergy and immunology at Northwestern University Medical School in Chicago. Dr. Bernstein is board certified in internal medicine, allergy/immunology and diagnostic laboratory immunology. He has authored and co-authored more than 100 publications in peer-reviewed medical journals as well as numerous reviews and book chapters. He has received federal funding to study occupational asthma and environmental determinants of allergy and asthma in children.

Jonathan A. Bernstein, MD, FACP, CCI

Dr. Jonathan A. Bernstein is a professor of clinical medicine in the Department of Internal Medicine, Division of Immunology/Allergy at the University of Cincinnati Medical Center, director of the Veterans’ Administration Hospital allergy clinic and allergy laboratory, and director of clinical research for its division of immunology. Dr. Bernstein is actively involved in clinical and translational research in addition to pharmaceutical research, patient care and teaching. His current research involves the investigation of indoor environmental determinants in the workplace and home that cause or aggravate asthma and rhinitis and the investigation of genetic markers that could identify susceptible populations to these exposures. Dr. Bernstein has extensive experience conducting clinical therapeutic trials and is a DIA-certified investigator. Dr. Bernstein has published more than 90 peer-reviewed articles, clinical reviews and chapters on a variety of allergic disease topics.

Sherry Evans, RN, MSN, CNP
Sub-Investigator – since 2002

Staff Expertise

Cheryl Bernstein, RN, BSN, CCRC
Director of Clinical Research Center – since 1982

Karen J. Murphy, BS, RRT, CCRC
Senior Clinical Research Department Supervisor – since 1988

Brian P. Berendts, RN, BSN, CCRC
Senior Certified Clinical Research Coordinator – since 2000

Other Information

BCRC works with centralized institutional review boards.