General Information
Profil is an internationally recognized research institute for clinical studies in the area of Diabetes mellitus and Obesity. In cooperation with the pharmaceutical industry, we perform clinical studies for the development and testing of new drugs and medical devices that are employed to combat Diabetes and Obesity. Activities in this area focus primarily on examining the efficacy and safety of new medicines and new administration methods (e.g. Insulin that can be inhaled) for Diabetes therapies, and on testing new diagnostic technologies.
In the following, you will find detailed information relating to clinical studies:
What is a clinical study?
Before a drug may be prescribed by a doctor, it must first be approved by the Food and Drug Administration (FDA). To obtain this approval, clinical studies must be carried out to establish the efficacy and safety of the drug. It is essential that these studies are carried out in accordance with precisely defined rules and conditions.
When the preclinical development phase has been completed successfully, i.e. in particular, on conclusion of the tests and experiments with animals, a new substance is tested on human subjects.
This testing is divided into four phases:
Phase I Studies:
The drug that is to be tested is administered to healthy people, known as subjects. These are people who volunteer to test - within the framework of a clinical trial (study) - new medical agents or agents that have not yet been approved in the United States. The aim of such Phase I studies is to gather information relating to the safety, the possible side effects, the pharmacokinetics (= study of concentrations of the administered drug in the blood) and pharmacodynamics (= start and end of the effect of the drug) of the drug.
Phase II Studies:
In Phase II studies, the drug is, for the first time, tested on patients suffering from the illness that is to be treated with this drug. Phase II studies aim to gather information on the efficacy, safety and the dose/effect ratio of the medication. Recently the FDA has allowed, or even encouraged patients with the illness to be entered into some Phase I studies.
Phase III Studies:
The drug that is being tested is administered to a larger number of patients. The aim in this phase is to examine the efficacy of the drug in day-to-day use, the possible side effects and safety as well as any possible interactions between medications.
Phase IV Studies:
These studies are only carried out after a drug has been approved.
A Phase IV study aims to gather further information relating to the benefits and risks associated with the drug as well as information on its use, for example, in other areas of application.
What must I know and do?
If you are interested in taking part in a clinical study at our institute,
please contact us:
Phone +1 (866) 308-7427
Fax +1 (866) 245-0647
E-Mail volunteer@profil-research.com
We would be happy to return your call and provide you with detailed information. You also have the option of completing the data sheet that is provided under Contact and sending it to us directly via our website or alternatively, you can print the form and send it to us by fax.
Why choose Profil Institute for Clinical Research?
We would be delighted should you decide to actively support our research for the benefit of people with Diabetes and, in so doing, make a personal contribution to the improvement of the medical care available.
We work hand in hand with a large number of renowned and recognized experts both at home and abroad - particularly in the area of Diabetes mellitus and Obesity. Through intensive communication with our contacts in the area of medical science, in clinics and in practices, we have become part of a network which, above all, provides access to the latest scientific findings. Numerous articles, published in a large number of high-ranking international journals, and presentations given at scientific congresses both at home and abroad vouch for our expertise.
How can I benefit from participating in a study?
- By participating in the clinical development of new substances and technologies, you are making a contribution to medical progress which will be of great benefit to those affected.
- Depending on the duration of the respective study and the manner in which it is executed, you will receive compensation.
The amount of compensation varies per study.
- In addition to a meeting with the doctor conducting the study, in which you will be provided with detailed information relating to the study and a medical evaluation, you will have access to your screening laboratory values and test results, which are often not done as part of routine medical care. This information can be provided to your regular physician at your request.
- You will be provided with information on new therapeutic possibilities.
- Your right to decide on whether or not to participate in the study
will not be infringed in any way.
What risks are associated with participating in a study?
We will, of course, make sure that the risks for you the patient/subject are kept to a minimum. This will be safeguarded by:
- Our many years of experience in carrying out clinical studies;
- Constant adherence to the legal guidelines (e.g. GCP = Good Clinical Practice;
- The monitoring of all studies by the Institutional Review Boards (guardians of ethical standards and subject rights for clinical trials);
- Medical care and control before, during and after the study:
24 hours a day, 7 days a week;
- The emergency control system at Profil and emergency training for all staff involved in the study to enable them to deal with an emergency as well as through
- The provision of insurance coverage for each participant in compliance with the legal requirements.
Whom can I contact if I am interested?
Profil Institute for Clinical Research Inc.
855 3rd Avenue, Suite 4400
Phone: +1 (866) 308-7427
Fax: +1 (866) 245-0647
E-Mail volunteer@profil-research.com
Do I receive compensation?
Yes. Compensation is determined by the length of the study and the manner in which it is executed. It can range between $500 and $4,500.
What happens to my data?
The information you provide will, of course, be treated as strictly confidential. All the details you provide relating to your person
(Name, First Name, Address, Date of Birth etc.) and to your medical history (current and previous illnesses, medication taken etc.) will be entered and saved in our Subject Database.
We guarantee that:
- Your personal and medical data will be treated as strictly confidential in compliance with the applicable laws and regulations
- Data relating to your medical history is safeguarded by the HIPAA. (Health Insurance Portability And Accountability Act)
- Your personal data will not be passed on to third parties without your prior consent and that
- All the data that we have saved relating to your person and medical history can be viewed by you at any time. At your request, all medical data relating to your person will be deleted.
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