Ellipsis Research Group Clinical Trials
Our exceptional dedication to research, provides the advancement that drives pharmaceutical therapies and device treatments for numerous health conditions, improving the quality of life of millions of people around our community through better health advocacy, with a global impact.
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About us
Type 1 Diabetes Type 2 Diabetes Gout Asthma COPD Obesity Influenza Urinary Tract Infection Hypertension Irritable Bowel Syndrome Cardiac Atherosclerosis
Our staff has over 35 years of combined experience conducting phase II-IV trials with strict adherence to GCP/ICH guidelines. Since its inception in 2010, Ellipsis Research has successfully managed over 80 clinical trials in partnership with over 20 pharmaceutical companies and counting. Our therapeutic expertise includes:
Caring for Our Little Heroes: Children with Diabetes in the United States
Caring for Our Little Heroes: Children with Diabetes in the United States In the United States, thousands of children face the daily challenge of living
The importance of clinical studies in the development of medicines and their impact
The importance of clinical studies in the development of medicines and their impact The importance of studies in the development of medicines is crucial for
Diabetes: Advances in Medicines and Tips for a Healthy Life
Diabetes: Advances in Medicines and Tips for a Healthy Life Diabetes is a disease that affects millions of people worldwide. It is estimated that approximately
Jorge Serje, MD
Principal Investigator
Jorge Serje, M.D. is an internationally accredited physician who is a Board Certified in internal medicine. As a graduate of Antioquia University in Colombia, Dr. Serje moved to New York in 1982 and completed his residency in Internal Medicine at Maimonides Medical Center in Brooklyn.
In 1991, Dr. Serje established New York Total Medical Care where he has served as the managing and senior partner since its inception. His practice is dedicated to serving the health care and wellness needs of individuals, families and the community at large. Through a wide array of diagnostic and subspecialty services, Dr. Serje and his staff provide patients with high quality and comprehensive medical care.
Sub-Investigator
Dr. Goldsen graduated from the Universidad De Guayaquil, College of Medical Science in 1978. With over 45 years of experience, Dr. Goldsen works in Brooklyn, NY and specializes in Internal Medicine and Hematology/Oncology. Dr. Goldsen is affiliated with Elmhurst Hospital Center, Henry J Carter Specialty Hospital & Nursing Facility, Hospital For Special Surgery, Mount Sinai Queens, and New York Presbyterian Brooklyn Methodist Hospital.
Silia M. Goldsen, MD
Joseph Kingsbery, MD
Sub-Investigator
Dr. Kingsbery graduated from Yale University in 2008 where he studied Molecular, Cellular and Developmental Biology with a minor in Spanish. He then attended Temple University School of Medicine where he was elected into the Alpha Omega Alpha Medical Honors Society and Gold Humanism Honors Society. Dr. Kingsbery continued his training at NYU Langone Health in Internal Medicine where he was voted Intern of the year (2014) and Resident of the Year (2015, 2016). He continued at NYU for Gastroenterology Fellowship where he was voted Fellow of the Year (2017). Dr. Kingsbery completed an additional year of advanced endoscopic training at Memorial Sloan Kettering Cancer Center, graduating in July 2020.
Our Facility
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- Security alarm system.
- Multi-functional examination rooms with bed.
- High speed broadband internet connection for RDE.
– Wired internet access.
– Wireless access for monitors’use. - CLIA Waived Laboratory.
- Secure, controlled access to sponsor and site study files.
- Secure climate-controlled drug storage with separate security monitoring.
- oxygen and emergency medications.
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Equipment includes.
– Imaging facilities in close proximity to site.
– Close proximity to hospitals and fire station (0.5 miles).
– Secure -20 C freezer.
- Secure -70 C freezer
– IATA Certified Staff.
– High speed centrifuge. - Refrigerated centrifuge.
- Solid-door pharmacy refrigerator.
– ACRP and SoCRA certified - – Autoclave.
– Spir<<ometer.
– ECG machines.
– Nebulizer.
- Secure -70 C freezer
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Testimonials
Everybody from the coordinators to the physician is very kind and knowledgeable; I truly enjoy coming here for my study visits. Plus, the study really helped me finally control my diabetes!
Evelyn Jimenez
Ever since I started this gout study I feel like I gained my life back, I have more freedom to do the things I like and more energy to enjoy my grandchildren
Debra Peters
I would definitely participate in another trial with Ellipsis Research. I was surprised by the professionalism and compassion with which they listened to my problems, explained all the trial procedures and put my mind at ease
Mark Martinez
FAQ
In the past, most drug testing had been done on white men. This means that some groups, such as African Americans, Hispanics/Latinos, American Indians, Asians, Pacific Islanders and women, had not always been included in the tests done on drugs.But sometimes drugs work differently in these people than on white men. So, the FDA wants people from many different groups included in these studies.
We at Ellipsis are committed to diversifying clinical trials by educating and affording access to these historically underrepresented minorities, by working with community leaders and primary care physicians.
Clinical trial” is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the product is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible.
By taking part in a clinical trial, you can try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people of different races and genders.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all. Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give. Phase 2 studies include more people than Phase 1 studies, and the people have disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:
- What is the study trying to find out?
- What kinds of test and exams will I have to take while I’m in the study? How much time do these take? What is involved in each test?
- How often does the study require me to go to the doctor or clinic?
- Will I be hospitalized? If so, how often and for how long?
- What are the costs to me? Will my health insurance pay for it?
- What follow-up will there be?
- What will happen at the end of the study?
- What are my other treatment choices? How do they compare with the treatment being studied?
- What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
- How long will the study last?
- Clinical trials are tests of medical treatments to see if they are safe and if they work.
- Before you agree to take part in a study, you must be given complete information about the study, including possible side effects and benefits.
- You should ask lots of questions to be sure you understand the study.
- You must sign a special agreement called “Informed Consent” before taking part in the study.
- The Informed Consent is not a contract. You can leave the study at any time
Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors don’t always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and all known risks should be fully explained to you by the researchers-
Informed Consent
To help you decide if you want to be in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:
- that the study involves research of an unproven drug or device
- the purpose of the research how long the study will take
- what will happen in the study and which parts of the study are experimental
- possible risks or discomforts
- possible benefits
- other procedures or treatments that you might want to consider instead of the treatment being studied
- that FDA may look at study records, but the records will be kept secret
- whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment
- the person to contact with questions about the study, your rights, or if you get hurt
- you can quit at any time.
Informed consents must be written so you can understand it. If you don’t, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.
Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.
Other Ways Volunteers Are Protected
Institutional Review Boards (IRBs)
Scientists, doctors and other people from the local community serve on IRBs to review and monitor their hospital’s or research institution’s medical research involving people. They monitor studies to help make sure that there is the least possible risk to volunteers and that the risks are reasonable in relation to the expected benefits. IRBs make sure volunteer selection is fair and that informed consent is done correctly.
Data Monitoring Committees
These committees are used mainly when one treatment is being compared with another. These committees are particularly important in tests of treatments for serious or life-threatening disease. These experts review information from studies to make sure they are being done in a way that is safest for the volunteers. During a study, if the committee finds that the treatment is harmful or of no benefit, it will stop the study. If a study shows that one treatment works better than another, the committee stops the study and all volunteers are offered the better treatment.
FDA Inspections
FDA inspects records and various scientists, clinics, and other research sites involved in a study. The agency does this to make sure volunteers are being protected and studies are being done correctly. From time to time such inspections are done in response to complaints.
Monitor Guidelines
We look forward to working with you and hope these guidelines ensure a more efficient use of your time and ours during your monitoring visit. Due to our current study volume and increased patient visit schedule we ask that you adhere to the following guidelines.
Please try and schedule your next SMV at each visit. This will allow us to adjust our schedule accordingly and give you adequate time during your visit with us. Also, please give us advance warning if you will be bringing a co-CRA or manager with you so we can accommodate everyone comfortably.
The Regulatory Coordinator is responsible for Regulatory and IRB questions (e.g. Site Delegation Logs, Enrollment Logs, & etc.). She/he will also be available to assist you.
We ask that Monitors do not walk to the back offices or exam rooms as we want to maintain privacy for our patients. If you need to talk with a study coordinator, please ask the front office for assistance.
For your convenience, there is a fax/copier machine available to you located in the front office. You are welcome to utilize this machine as needed, but we do ask to please keep copying to a minimum and to only make copies concerning our site.
Partners / Collaborators
We are always seeking physicians to expand our collaborative network of Investigators.
We firmly believe in the advancement of medical science through the conduct of high quality clinical trials, while improving patient care by allowing the patients to take a more active role in their own health care.
If you are interested in joining our ever expanding network, please contact us.
We have conducted over 50 phase II through IV clinical trials to date.
Below, some of our sponsors: