Frequently asked questions about participating in a clinical trial
Below are some frequently asked questions related to clinical studies. If you have any further questions, please contact us by email at firstname.lastname@example.org or calling us at +1 (866) 308-7427. We are happy to answer any questions you have.
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 effectiveness and safety of the drug. It is essential that these studies are conducted in accordance with precisely defined rules and conditions.
First, a new drug or device candidate enters preclinical development. This is a stage of research that is completed before testing in humans, and during which important feasibility, iterative testing and drug safety data is collected. After preclinical development, the drug or device candidate enters into clinical trials, which are divided into four phases. Profil Institute for Clinical Research, the CRU division of ProSciento, Inc. performs early phase clinical studies. We are not involved in preclinical or later stage clinical trials. Below is more information about phase I and phase II clinical trials as well as the later phase trials. In phase I trials, researchers test an experimental drug or treatment in a small group of people, generally 20-80 study participants, to evaluate its safety, determine a safe dosage range, and identify side effects. In phase II trials, the experimental study drug or treatment is given to a larger group of people, generally 100-300 study participants, to see if it is effective and to further evaluate its safety. In phase III trials, the experimental study drug or treatment is given to large groups of people, generally 1,000-3,000 study participants, to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. In phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.
If you are interested in taking part in a clinical study at our facility, please contact us:
Phone +1 (866) 308-7427
Fax +1 (866) 245-0647
We would be happy to provide you with detailed information about becoming a study participant. You also have the option of completing our contact form 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, the CRU divison of ProSciento, Inc.?
We would be delighted should you decide to 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.
Our advances in early phase drug research and its specific focus on diabetes, obesity and cardiometabolic diseases have led Profil Institute for Clinical Research, the CRU division of ProSciento, Inc. to be the most highly regarded clinical research institute for early phase diabetes drug trials. To date, we have completed more than 250 clinical studies covering every clinically relevant drug category and device development in diabetes since the company’s inception in 2003. Our key scientists hail from academic centers including the WHO Collaborating Center of Diabetes at the Heinrich-Heine University of Düsseldorf, Columbia University, University of Michigan and Harvard University. Numerous articles published in a large number of high-ranking international journals and presentations given at global scientific conferences vouch for our expertise.
By participating in the clinical development of new therapeutics 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.You will also participate in a medical evaluation with the doctor conducting the study. 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.
What risks are associated with participating in a study?
We will, of course, make sure that the risks for you the study participant are kept to a minimum. This will be safeguarded by:
Our many years of experience in carrying out clinical studies
Adherence to legal guidelines (e.g., GCP = Good Clinical Practice)
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
Emergency control systems at our facility and emergency training of our staff involved in the study
The provision of insurance coverage for each participant in compliance with legal requirements
Who can I contact if I am interested?
Profil Institute for Clinical Research, the CRU division of ProSciento, Inc.
855 3rd Avenue, Suite 4400
Phone: +1 (866) 308-7427
Fax: +1 (866) 245-0647
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 $25 and $7,000.
What happens to my data?
The information you provide will be treated as strictly confidential. All the details you provide (name, first name, address, date of birth, medical history, current and previous illnesses, medication taken, etc.) will be safeguarded in our highly confidential study participant 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. All data that we have saved related to you and your medical history can be viewed by you at any time. At your request, all medical data related to you will be deleted.