Research Center Profile:
Cardiology/Vascular Diseases
AAIR Research Center is located in Rochester, NY, an area that has a tradition for supporting medical research. It is a division of Allergy Asthma Immunology of Rochester, P.C. a multi- specialty group practice, specializing in allergy, asthma, pulmonary, pain, and the rheumatic diseases. The practice was started in 1985 and has grown to include eight doctors, three nurse practitioners, and 4 locations. The practice is closely affiliated with a major teaching hospital. The Research Center has seven doctors and a nurse practitioner who are all experienced in clinical trials. The center is headed by Dr. John J. Condemi who has been actively involved in research for over 40 years . He has performed Phase 2, 3 and 4 pharmaceutical clinical trials and non-sponsored pharmaceutical research studies since 1969. Dr. Donald Pulver is the principal investigator for sinusitis studies. Drs. Peter Deane,Emmanuel Quaidoo , and Anatole Kleiner are principal investigators and sub-investigators in both allergic, pulmonary, and rheumatic disease studies. Dr. Albert Hartel is a sub-investigator in allergy and pulmonary studies . All investigators are trained in Human Subjects Protection and GCP. Curricula vitae are available on request. The center employs an administrator to expedite regulatory applications, a regulatory assistant and a recruiter to facilitate rapid study enrollment. The center also employs four nurse study coordinators three of which are certified by the Association of Clinical Research Professionals.
The Center has 2,400 sq. ft. of dedicated space, including four exam rooms. We can perform on site 8-12 hour studies, including studies requiring intravenous infusions. The center has the flexibility of being able to use a central IRB. Phlebotomy is done at the center and there is a laboratory on site. The Center has a centrifuge, -20° freezer, adequate locked refrigeration space for refrigerated study medication, and climate controlled locked drug storage. We make our own dry ice for frozen lab specimen shipment. Our center has a KoKo spirometer, Burdick EKG machine, and stadiometer. We have a fiberoptic rhinolaryngoscopy for sinusitis studies requiring antral punctures and sinus cultures. We are an AAAAI approved aeroallergen pollen and mold center. The medical center we are in is near an ambulatory care center where endoscopic and special procedures are performed. The center has a large database that draws on the private practice and volunteers from previous studies.
The Center has comfortable, spacious monitor accommodations. We
are conveniently located to the airport and area hotels.
John J. Condemi, M.D. Medical Director of Research Center and Primary Principal
Investigator
Dr. Condemi has extensive experience in conducting clinical trials. He has been actively conducting clinical trials since 1969. He has been the principal or sub-investigator on approximately 350 trials. He has performed Phase II, III, and IV pharmaceutical clinical trials and non-sponsored pharmaceutical research studies. Dr. Condemi is one of the founding partners of Allergy Asthma Immunology of Rochester, PC. He is a Fellow in the American Academy of Allergy Asthma and Immunology (AAAAI), the American College of Allergy Asthma and Immunology (ACAAI), American College of Physicians (ACP), American College of Rheumatology (ACR) and is a member of the New York Academy of Science. He has been and currently is on the Boards of numerous organizations, has received many awards for outstanding service. He has been elected by his peers as one of the best doctors in America every year since 1976. He has been recognized as one of America's well-known specialists. Dr. Condemi received the Rochester Academy of Medicine’s prestigious Albert David Kaiser Medal in 2008 for distinguished service in the fields of medicine, public health and community welfare. He has served on several editorial boards and has published many papers, abstracts, and chapters. Dr. Condemi's therapeutic and research interests lie "wherever the immune system goes".
Donald W. Pulver, M.D. Principal Investigator for Sinusitis Studies and Sub-Investigator in other therapeutic areas
Dr. Pulver has conducted Phase II, III, and IV clinical trials at AAIR since 1985. He became the principal investigator on sinusitis trials in 1991 and continues as such. Dr. Pulver is one of the founding partners of Allergy Asthma Immunology of Rochester, PC. He is a fellow in the American Academy of Allergy and Immunology (AAAAI), American College of Allergy and Immunology (ACAAI), and the Joint Council of Allergy and Immunology. He has been Chairman of the Aerobiology Committee for the American Academy of Allergy Asthma and Immunology (AAAAI) and instructs workshops on fiberoptic rhinolaryngoscopy at the AAAAI annual meetings. He was the Chairman of the National Allergy Bureau of Aerobiology for three years. Dr. Pulver is responsible for collecting, counting , and reporting the pollen counts in our area. His therapeutic and research interests lie in acute and chronic sinusitis, rhinitis, allergy, and asthma.
Peter M.G. Deane, M.D. Principal Investigator / Sub-Investigator
Dr. Deane is a graduate of the University of Rochester School of Medicine and completed National Board of Medical Examiners certification in 1990. He is board-certified in Allergy and Immunology (by ABAI) and Rheumatology (by ABIM). He is also certified in Clinical Densitometry (by ISCD). Dr. Deane was recently elected to the Board of Directors at the Monroe County Medical Society.
Dr. Deane has conducted Phase II, III, and IV clinical trials at AAIR since he joined in 1998. He is a fellow in the American Academy of Allergy Asthma and Immunology (FAAAAI) and the American College of Rheumatology (FACR). Dr. Deane is currently a peer reviewer for the Journal of Allergy and Clinical Immunology and Pediatrics. He has published several abstracts, articles, chapters and co-authored a book Dr. Deane’s therapeutic and research interests lie in allergy, asthma, clinical immunology and rheumatic diseases.
Emmanuel A. Quaidoo, M.D. Principal Investigator / Sub-Investigator
Dr. Quaidoo has been conducting Phase II, III, and IV clinical trials at AAIR since he joined the practice in 1998. He is a fellow in the American Academy of Allergy Asthma and Immunology (AAAAI), and a member of the Allergy Sub-Committee of the Rochester Individual Practice Association. He has published a book chapter and several abstracts and articles. Dr. Quaidoo's therapeutic and research interests lie in allergy, asthma and rheumatic diseases.
Albert S. Hartel, M.D. Principal/Sub-Investigator
Dr. Hartel has been involved in research since 2000 and has been conducting Phase II, III, and IV clinical trials at AAIR since he joined the practice in 2006. He is a fellow in the American Academy of Allergy Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI). He is a member of the Finger Lakes Allergy Society. He received the first ever Resident Excellence in Teaching Award. Dr. Hartel has published several articles and has two research publications pending. Dr. Hartel's therapeutic and research interests lie in allergy and asthma.
Anatole K. Kleiner, M.D. Principal/Sub-Investigator
Dr. Kleiner has been involved in research since 1995. He has been a sub-investigator for Phase II, III, and IV clinical trials since joining AAIR in 2008. He is a fellow in the American Academy of Allergy Asthma and Immunology (AAAAI), the American College of Rheumatology (ACR), and the American Medical Association (AMA). Dr. Kleiner has published several articles and abstracts. His therapeutic and research interests lie in allergy, asthma, and the rheumatic diseases.
J.D. Brederson, MS, RN, FNP Sub-Investigator/Enrollment Liaison
JD has been involved in research since joining AAIR in 2012. He is a Sub-Investigator in Phase II, III, and IV clinical trials and the site’s enrollment liaison for all studies. He is a past Crisis Intervention Specialist and a Certified Alcohol and Drug Abuse Counselor. JD’s interests lie in research, allergy and the rheumatic diseases.
Becky Ricotta, MS, CCRC Research Administrator
Joyce Greenwood, LPN, CCRC Certified Clinical Research Coordinator
Amy Wielgosz, RN, CCRC Certified Clinical Research Coordinator
Tina Champaigne, RA Research Assistant
Dee Doyle, LPN, CCRC Certified Clinical Research Coordinator
Lisa McKelvie, RN, CRC Certified Clinical Research Coordinator
All staff excel in subject recruitment and provide individualized attention to each of our subjects. Our staff is IATA and ACRP certified. They have received training in GCP and human subject protection. All staff is experienced in remote data entry and electronic diaries. We have a regulatory specialist to expedite regulatory applications and contract negotiations.
AAIR Research Center is located in Rochester, NY. The Rochester
area has a population of 1.2 million people. Rochester is the home
of the University of Rochester Medical Center, Rochester General
Hospital who has an affiliation with the Cleveland Clinic, Kodak,
Bausch & Lomb and Xerox. All these companies are continuously
conducting research. The Rochester population supports this
research and is very interested in its progress. Rochesterians are
educated in the importance of ongoing research and are excited to
participate as volunteers.
AAIR Research Center's database includes not only patients
who have participated in previous clinical trials, but also
patients from the AAIR practice. The practice has over 10,000
patients. There are 3,719 patient visits per month. On the average,
2,789 patients per month are treated with allergic and immunologic
problems and 930 patients are treated with rheumatic disease.
The characteristics of our patient population are as
follows:
40% male and 60% female
93% white and 7% minorities
Of the pediatric population 50% is between the ages of 0-12 and
50% is between the ages of 13-18
Of the adult population 50% is between the ages of 19-50, 40%
is between the ages of 51-75 and 10% is over 75 years of
age
The Center has Standard Operating Procedures in place encompassing all aspects of conducting clinical trials. The staff is well trained by the Center's training program, which includes continuing education. The coordinators are ACRP certified when eligible and all coordinators are IATA certified. All staff have completed GCP training and the Certification Program in Human Participant Protections Education for Research Teams sponsored by the U.S. National Institute of Health and National Cancer Institute. . GCP and Human Subject Protection Training are updated at the minimum every two years. Our Center is HIPPA and OSHA compliant. Our laboratory is a New York State CLIA Certified Limited Service Laboratory.
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the email form below. A representative from
the research center will then follow up with you.
