Frequently asked questions about participating in a clinical research study

Below are some frequently asked questions related to clinical research studies. If you have any further questions, please contact us by email at volunteer@prosciento.com or call us at +1 (866) 308-7427. We are happy to answer any questions you have.

What is a clinical research study?
What must I know and do?
Why choose ProSciento?
How can I benefit from participating in a study?
What risks are associated with participating in a study?
Who can I contact if I am interested?
Do I receive compensation?
What happens to my data?

What is a clinical research 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 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. ProSciento 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.

What must I know and do?

If you are interested in taking part in a clinical research study at ProSciento, please contact us:
Phone +1 (866) 308-7427
Fax +1 (866) 245-0647
email: volunteer@prosciento.com

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 ProSciento?

We would be delighted should you decide to support our research for the benefit of people with diabetes, NASH, and related metabolic diseases, and, in so doing, make a personal contribution to the improvement of the medical care available.

At ProSciento, our mission is to advance the global development of improved therapeutics to treat diabetes, NASH and obesity, and to support the patient and research community through advocacy group and outreach programs.  We are widely recognized for our quality and scientific excellence, an unparalleled methodological toolkit, and extensive experience. To date, we have completed nearly 300 clinical trials covering virtually all diabetes drug and device categories 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. Our key scientists are highly respected in the scientific community. Their peer-reviewed articles are regularly published in high-ranking international journals and study outcome presentations are given at global scientific conferences.

How can I benefit from participating in a study?

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?

ProSciento
855 3rd Avenue, Suite 4400
Phone: +1 (866) 308-7427
Fax: +1 (866) 245-0647
Email volunteer@prosciento.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 $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.