Center Overview
The Bernstein Clinical Research Center has been conducting clinical research studies since 1969. Our Center has conducted over 500 clinical trials in the 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 non-respiratory clinical trials for dermatological disorders (e.g., urticaria, hereditary angioedema, atopic dermatitis) migraines, hypertension and gastroesophageal reflux disease (GERD).
Our physician investigators are board certified internists and allergists, 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.
The clinical research staff is highly trained and experienced. The center is staffed by four certified clinical research coordinators (CCRC). The study research team includes a nurse practitioner, a former critical care nurse, a registered respiratory therapist and other well trained clinical research professionals.
Clinical Research Experience
The Clinical Research Center conducts Phase I, II, III, and IV clinical trials for many large and small pharmaceutical companies. Our research center has gained a reputation for excellence in source documentation, complete case report forms and rigorous attention to detail. For years, our staff has built a reputation for consistently meeting randomization goals with qualified subjects. Due to rigorous and careful screening, our Center has enjoyed high completion rates with minimal numbers of screen failures. The Bernstein Clinical Research Center is able to work with centralized Institutional Review Boards. We have successfully completed many sponsor and FDA audits.
Facility Description:
The Bernstein Clinical Research Center facility meets all regulatory requirements of ICH/GCP and FDA . Our staff is IATA certified for lab shipment.
- 6000 square foot, state-of-the-art facility equipped to do Phase I, II, III and IV clinical trials
- Phase I Unit (16 beds)
- Private rooms for conducting the Informed Consent Form Process
- 3 locked and secure drug storage facilities equipped with a Refrigerator & -40 Freezer
- Onsite archiving locked storage facility
- Private study interview/exam patient rooms
- Patient Lounge for 4, 12 hour studies
- Private space for monitors and audits
- Dedicated and secure space for research staff
- Skin testing rooms
- Laboratory specimen processing area, refrigerated centerfudge, -30 Freezer
- Electrocardiogram & Holter monitoring room
- 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 SOP’s and job descriptions for clinical research staff
- Crash cart and defibrillator equipment
Respiratory Clinical Trials
- Pulmonary Function equipment and DLCO
- Exercise Induced Asthma Challenge equipment and room
- Perform specialized Methacholine and challenge testing
- Fractional Expired Nitric Oxide Test (ENO)
- NIOSH approved instructor
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