Bioequivalence Studies

We conduct

  • FIRST-INTO MAN STUDIES
  • FEASIBILITY STUDY
  • PROTOCOL DEVELOPMENT
  • SITE IDENTIFICATION
  • CLINICAL INVESTIGATOR SELECTION
  • CLINICAL STUDY MONITORING
  • CLINICAL TRIAL CO-ORDINATION
  • CLINICAL TRIAL PROJECT MANAGEMENT
  • INDEPENDENT ETHICS COMMITTEE SUBMISSION
  • REGULATORY SUBMISSIONS
  • POST MARKETING SURVEILLANCE\

What is bioequivalence?

Bioequivalence is a clinical research study that seeks to compare a medication produced by two different companies. One of the two medications is already marketed whereas the other isn’t.

What is the advantage of participating in a Bioequivalence Study?

IBSPS shall pay you remuneration for the inconvenience caused to you as a participant for the study.

Besides, you are performing a social service of the highest quality by participating in a study, because only after these medicines are proven safe and effective (through you volunteers), do they get permission to go to the market. In this way, you help bring quality medicines to the market.

Can I participate in several studies?

Yes. Volunteers can participate in several studies. However, you can never participate in more than one study at the same time. In addition, you have to comply with a waiting period (3-4 months) between studies. This waiting time is determined by the volume of blood taken during the study and the administration of the medication (the waiting period will enable your blood to replenish itself).

Can volunteers from remote areas participate?

Yes. Volunteers from remote areas are welcome to take part in our studies.

Can I go to work after participating in a session, as part of a study, and receiving medication?

Yes. Participation in a study will not prevent you from pursuing your normal activities.

Can I leave your premises during a stay required by a study?

No. A stay is a confinement, and you will not be allowed to leave the premises for a predetermined period of time. You will be notified about this length of time.

Are there private rooms?

No. All volunteers sleep in a shared sleeping area. Only mixed studies require gender-specific sleeping areas.

Are there bathing facilities?

Yes. We have all of the conveniences needed for showers.

Should I take time off work to be eligible for participation?

No. We cannot guarantee participation in a study ahead of time. We have to wait for the laboratory results before we can confirm your participation.

If you have any suggestions in order to expand these frequently asked questions, please feel free to contact our recruiting executives in the clinical research department. They will be glad to take down your comments and questions.

Can a woman volunteer participate in this study?

Yes, IBSPS also conducts studies with healthy women volunteers as well as postmenopausal women volunteers. Male and female volunteer studies are conducted separately.

Opening the File

To take part in a study, you must first fill out a questionnaire. The information gathered will enable IBSPS to establish your profile and offer you studies you are best suited for. A file number will be assigned to you. It will identify you whenever you get in contact with IBSPS.

Assessing the Candidate

Once your file has been completed, our recruiting executive will identify a study that perfectly matches your profile and availability. They will then book an appointment for a medical examination. You will see a physician who will assess your health by giving a general examination: measuring weight, height, and body frame, urine test, blood sample, electrocardiogram, and urine testing for drug abuse (if required). You may also be asked to undergo an alcohol breath test. By going through all this, we wish to assure both you and ourselves that we will not endanger your health in any way. We also wish to make sure that nothing about your physical condition will distort the results of the study in which you may be asked to participate.

Selection

If the results of your medical exam are satisfactory, one of our recruiting executives will get in touch with you to confirm whether you are interested in participating in a given study. If the number of volunteers available should exceed our needs for that study, we will try to find another one that suits you. Helping volunteers participate is essential to our success, so we will do everything possible to pave the way for your participation.

Stages of the Study

Once you have been accepted for a study, you will go through the following stages:

Complying with Restrictions

Before showing up for your first stay, you will have to comply with certain restrictions that our recruiting officer will explain to you in due time. Restrictions are imposed to make sure nothing will distort the results of exams during the study or affect your safety.

Checking In

On the first day of the study, you will check in at the agreed-upon time and place, usually around 6 p.m. You will be asked to sign an “Informed Consent Form” that will give an overall view of the study and its implications while explaining what is involved. Your belongings will be checked during the welcoming session and put safely in our custody. Supper will then be served and you will be free for the rest of the evening – while remaining bound by the restrictions as well as staying on the premises of IBSPS. The administration of the drug medication will take place the next morning.

Following the Rules

The selection officer will inform you of the rules when he/she confirms your participation in a study.

Staff

The study will be carried out under the supervision of a complete, competent team of medical personnel. An attending physician will be available at all times in the event of a participant having an abnormal reaction to the medication. Although the risk is low, it remains possible, and we are ready to deal with it at any time.

Living Conditions and Meals

During the course of the study, all volunteers must comply with a standard diet. The amount of food and liquids is determined in advance. There may be a critical meal during your study, i.e., a meal where you have to eat everything within a certain lapse of time. If you have any intolerances, food allergies, or special needs, tell your recruiting executive. All volunteers must comply with the established schedule. You will have to go to bed at a set time, usually around 10 p.m. The wake-up call is generally around 6 a.m.

During the study, you will have lots of free time for watching television, playing board games, reading, doing personal work, or just relaxing.

Taking the Medication

On the first morning of each stay, around 8:00 a.m., you will have to take the study drug medication.

Taking Blood Samples

After the medication has been taken, we will take blood samples at regular intervals to see how the medication is being absorbed into the blood and how it is dissolving in the bloodstream. In general, there should be between 15 and 23 blood draws per period (one stay and the subsequent return visits). This number may vary according to the medication. When possible, we use a catheter (a flexible tube that is inserted into the vein and remains in place for a predetermined length of time so that several blood samples can be taken without having to reinsert the needle each time) to spare you the discomfort of multiple blood draws. If your veins are more sensitive than average, you can tell the recruiting officers you wish to participate in a study in which a catheter is used or one in which urine samples are collected.

Leaving

You may leave early in the morning or in the evening. We will remind you of the restrictions that apply for the rest of the study and the dates and times of the return visits, if any.

Return Visits

Many studies require return visits. During these visits, we take blood samples. The visits are usually early in the morning, between 6:30 and 9:00 a.m. Occasionally, there may be an evening return visit.

Financial Compensation

Our volunteers always get financial compensation. This amount is calculated in terms of the time you have spent at IBSPS, the number of return visits, and, of course, the proportion of the study you have completed. We will pay you an amount after each stay and, at the very end of the study, a check for the amount still owed.

Complying with Restrictions

Each study has restrictions that must be observed. The criteria for each study may vary. Check with our Clinical Research executive as to whether your specific situation matches our selection criteria.

Adverse Events

While participating in a study, you may experience an adverse event after taking a medication. Our experience has shown that most of our volunteers feel no significant adverse effects. The reason is simple: our selection process is extremely rigorous. Our volunteers must be healthy and a series of tests will confirm their condition. You will be informed about the results of your examinations if we find anything wrong.

The possible adverse events are those that are associated with regular use of the medication. Although you will be taking only a few doses, you may experience some of the effects. The intensity may vary from one medication to the next and from one individual to the next.

Our qualified staff will be happy to answer your questions on this subject.

Policy of Confidentiality for Internet-based Volunteer Recruiting

This is IBSPS’s policy on gathering information over the Internet and the choices you have as a user.

IBSPS will help you select the studies you may be interested to participate in. We are aware that the information you send us is confidential and we have developed several safety rules to protect your privacy.

Your file will be kept in our database only if you give us permission to contact you when clinical studies matching your profile come up. You may, at any time, change or remove personal information kept in IBSPS’s database.

IBSPS will not contact you via e-mail if you do not wish us to do so.

Statistics from our database will be generated in such a way that the identity of the volunteers will remain confidential. As well, no personal information can be associated with a specific subject in the preparation of statistical reports.