Center Overview
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.
Our Code of Ethics
1. We consider the safety and welfare of our patients and clinical study subjects to be our highest priority.
2. We uphold the highest scientific standards of objectivity, accuracy and integrity.
3. We comply with all applicable laws, regulations and guidelines, as well as Company policies and procedures that govern legal and ethical conduct.
4. We conduct clinical studies only if there is no undue cost or risk to the subjects, and only if they benefit the general public.
5. We engage in only those research activities for which we are knowledgeable and competent.
6. We enroll only qualified and properly-consented subjects in clinical trials.
7. We do not discriminate against any potential subject based on race, gender, age, religion, national origin, sexual orientation or disability.
8. We do not coerce or unfairly influence people to participate in clinical studies.
9. We avoid conflicts of interest and do not offer or accept improper inducements.
10. We protect the confidential information of subjects and patients.
11. We speak and write the full and accurate truth; we do not improperly withhold information.
12. We do not engage in ethically-unclear activities until the ethical questions are resolved.
13. We challenge or report unethical conduct to the Medical Director.
14. We work together to understand and resolve ethical issues.
Disclaimer: This Code of Ethics is a statement of good-faith intentions. It does not constitute any contractual or legal obligation beyond that required by
applicable laws and regulations.
2. We uphold the highest scientific standards of objectivity, accuracy and integrity.
3. We comply with all applicable laws, regulations and guidelines, as well as Company policies and procedures that govern legal and ethical conduct.
4. We conduct clinical studies only if there is no undue cost or risk to the subjects, and only if they benefit the general public.
5. We engage in only those research activities for which we are knowledgeable and competent.
6. We enroll only qualified and properly-consented subjects in clinical trials.
7. We do not discriminate against any potential subject based on race, gender, age, religion, national origin, sexual orientation or disability.
8. We do not coerce or unfairly influence people to participate in clinical studies.
9. We avoid conflicts of interest and do not offer or accept improper inducements.
10. We protect the confidential information of subjects and patients.
11. We speak and write the full and accurate truth; we do not improperly withhold information.
12. We do not engage in ethically-unclear activities until the ethical questions are resolved.
13. We challenge or report unethical conduct to the Medical Director.
14. We work together to understand and resolve ethical issues.
Disclaimer: This Code of Ethics is a statement of good-faith intentions. It does not constitute any contractual or legal obligation beyond that required by
applicable laws and regulations.
CRA Testemonials about Our Site
Having monitored multiple studies at AAIR over the years, I find it to be a consistently good site to work with, in terms of the site staff, the PI, the facility and their recruitment efforts.
Facility- the facility is a designated for research activities with necessary equipment rooms, safe/secure investigational product and documentation areas, laboratory facilities, patient rooms and waiting area. There is ample room for monitoring with computer access.
Site staff- the site staff professional, knowledgeable, and always helpful in putting forth extra effort to get things done correctly and in a timely fashion.
They each have their specific roles at which they are the trained point person (budget, regulatory, study coordinator) which helps things runs smoothly
during the study.
PI- the PI is involved with the study and the subjects. He is an active participant in monitoring visits and readily available for trainings or discussions as
needed.
Recruitment- the staff does a good job of projecting the potential subjects they will enroll into a study. The coordinators are actively involved in recruitment and are motivated to reach their target numbers.- J.S., CRA
Facility- the facility is a designated for research activities with necessary equipment rooms, safe/secure investigational product and documentation areas, laboratory facilities, patient rooms and waiting area. There is ample room for monitoring with computer access.
Site staff- the site staff professional, knowledgeable, and always helpful in putting forth extra effort to get things done correctly and in a timely fashion.
They each have their specific roles at which they are the trained point person (budget, regulatory, study coordinator) which helps things runs smoothly
during the study.
PI- the PI is involved with the study and the subjects. He is an active participant in monitoring visits and readily available for trainings or discussions as
needed.
Recruitment- the staff does a good job of projecting the potential subjects they will enroll into a study. The coordinators are actively involved in recruitment and are motivated to reach their target numbers.- J.S., CRA
Highly competant and knowledgable site with extremely involved PIs. Rapid turn around of regulatory documents ensuring the site will be up and running in a timely manner. - J.D., CRA
AAIR is committed to effective study recruitment and enrollment through targeted advertising, social media, and a current pool of patients from their practice who are interested in clinical research. AAIR exceeded our recruitment targets, and beat our enrollment timelines. The study coordinator is dedicated to recruiting high quality subjects, who are appropriate for the study and are committed to completing the entire study. Data collection, data
entry, and query resolution are taken seriously in order to meet the sponsor’s guidelines and timelines.
The AAIR staff are technically proficient with the complex study related equipment and maintenance required. They have experience with multiple EDC
platforms, IVR systems, and other online management programs used by the sponsor. Investigational Product (IP) accountability is thoroughly managed and their subjects are well informed about the importance of compliance with the dosing regimen and processes.
My PI, Dr. Condemi is an avid supporter of clinical research. He stays current with regulatory and therapeutic changes in the industry, and is available to meet with me whenever needed. The staff has a productive working relationship with him and he’s able to turn around sponsor requests quickly.
The AAIR staff are committed to meeting sponsor data deadlines and regulatory deadlines by working together. They provide adequate backup coverage
in the event that primary contacts are out of the office. Attention to detail is evident with the collection of high quality data and clear source documentation. But in the event that errors are discovered, AAIR is dedicated to quality oversight and resolution. The staff works together to provide quick resolution along with corrective action plans and preventative action plans. The oversight of quality at AAIR is evident starting from the study
coordinator and regulatory coordinator, up through the research manager and ultimately with the PI. ~N.S., CRA
entry, and query resolution are taken seriously in order to meet the sponsor’s guidelines and timelines.
The AAIR staff are technically proficient with the complex study related equipment and maintenance required. They have experience with multiple EDC
platforms, IVR systems, and other online management programs used by the sponsor. Investigational Product (IP) accountability is thoroughly managed and their subjects are well informed about the importance of compliance with the dosing regimen and processes.
My PI, Dr. Condemi is an avid supporter of clinical research. He stays current with regulatory and therapeutic changes in the industry, and is available to meet with me whenever needed. The staff has a productive working relationship with him and he’s able to turn around sponsor requests quickly.
The AAIR staff are committed to meeting sponsor data deadlines and regulatory deadlines by working together. They provide adequate backup coverage
in the event that primary contacts are out of the office. Attention to detail is evident with the collection of high quality data and clear source documentation. But in the event that errors are discovered, AAIR is dedicated to quality oversight and resolution. The staff works together to provide quick resolution along with corrective action plans and preventative action plans. The oversight of quality at AAIR is evident starting from the study
coordinator and regulatory coordinator, up through the research manager and ultimately with the PI. ~N.S., CRA
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