The THERAPHARM Research Center was founded in 1980 and was approved by the French Ministry of Health in accordance with applicable regulations (20/12/1988). There are approximately 80 people employed by the Company, including physicians, nurses, pharmacists, etc.
Since 1998, 14 phase-I studies were conducted in 340 Japanese volunteers.
Since 1980, approx. 70 studies were carried out yearly in Caucasian volunteers (western).

All currently marketed medicines could only been released because some volunteers agreed to participate in tests. Your efforts will hence be an invaluable aid to continue developing new drugs.

Studies in Japanese volunteers in France: Why?
Some medications may affect Japanese and European subjects differently or, on the contrary, similarly. For this reason, safety and blood drug concentrations may have to be assessed in both populations. Such studies are carried out in France where it is possible to investigate both populations under similar conditions in order to minimize any effect due to  living conditions.
Moreover, Japanese Health Authorities also require that additional investigations be conducted even for already marketed medications before they can be authorized in Japan.

Your participation is not mandatory
You are not obliged to participate in a study once you have registered; you can make a decision freely after you have been fully informed of the product and study characteristics, and ask any question you may like to raise. You are entirely free to refuse your participation in a study if this is not convenient to you.

Informed Consent Forms
During the screening tests, both you and the study Investigator will jointly have to sign an Informed Consent Form and you will keep a copy of it. If you do not sign this Informed Consent Form, you cannot start the study. When you have agreed to participate, you can also terminate the study at any time.

About safety
Any study must be conducted in accordance with French health regulations.
Each study must be carefully evaluated by an Ethics Committee before it is initiated and the project may be stopped if there is any doubt in terms of safety.

What is a Committee for the Protection of Persons (CPP)?
A CPP is an ethics committee protecting volunteers who participate in a clinical study. It consists of physicians, psychologists, nurses, pharmacists or even lawyers, who are not directly involved in a project. Each project is assessed in terms of safety, scientific and ethical aspects. In order to preserve impartiality, any doctor or person involved in the project is not allowed to participate in the deliberations.

About adverse events
Although medications are carefully administered during a study, it cannot be excluded that no adverse events will occur. Moreover, adverse events do not only impact clinical studies; all previously authorized medications may produce adverse events, which are dependent on the subject's nature. 
You will be informed of them if you have a look at the package insert: they must be reported there.
Each medication produces two types of effect: first of all, the main effect, which alleviates symptoms (curative) and the other, an adverse effect, i.e. other than the originally expected action. The study investigator periodically examines subjects and if any adverse event is reported, he immediately takes the required actions.

Confidential information
Strict confidentiality is maintained by law for healthy volunteers who have participated in a study and no personal data will be disclosed (name, address, etc.) to others outside  THERAPHARM.

Indemnification criteria
If you volunteer to participated in a study, you have constraints and rules to follow, e.g. to stay in the research center throughout the planned study period or comply with certain daily life rules.
An allowance will be paid in compensation for your imposed constraints. This is neither a reward nor a compensation for any danger. The amount of money paid depends on the study and the resulting constraints in terms of time and examinations and this is validated by the CPP. This money is not liable to the income tax.

Japanese language assistance
If you ask yourself any question, even after the start of the study, concerning examinations, medications or any other subject relating to the study, you may have detailed explanations from the doctors or nurses in charge at any time. Japanese volunteers can gain language assistance from Japanese-speaking employees within THERAPHARM.

To participate in a study
If you are interested in participating in a clinical trial, you must first have an interview, then register. If you have not understood anything during this interview, feel free to ask as many questions as you wish to and you will make your decision to participate when you have  understood everything. If you choose to participate, you will have to undergo a medical checkup free of charge, which will enable the doctor to see whether or not you are medically suitable for participation.
Based on your test results, you may not be allowed to participate in the clinical study. In this case, you will not receive any financial compensation (for Japanese recruited outside Caen, transportation costs will be reimbursed).

Stay at the Therapharm site
Throughout the study period, you must stay at the THERAPHARM site under medical control. During the study, you will have to take the medication complying with the established timing and procedure. You will undergo various examinations during the planned visits (blood tests, urinalysis, body weight measurement, blood pressure recordings, ECG, etc). You must report any experienced symptom during your hospitalization. The stay time and number of doses depend on the type of study.

It is strictly prohibited to go out of the hospital during your stay. You must be in your room during examinations. Outside the examination times, you may watch TV, video movies, read, play games or study when inside the hospital.

Meals
Meals are served during the study. You are offered well balanced meals according to the planned schedule.

For more information
We are permanently seeking male and female volunteers. European volunteers must hold a European Health Insurance card. Be welcome to our Caen site for further information of the study details. Feel free to contact us at the following phone number 02 31 53 63 03 or visit us at the following address: 5, boulevard H. Becquerel – 14052 CAEN (France), close to the Faculty of Pharmacy.

A special cell is dedicated to the inclusion of Japanese volunteers (male or female). Feel free to contact us at the following phone number 01 46 99 94 00 (Japanese/French, Japanese volunteer-only line) or visit us at the following address: 60 rue Carnot – 92100 BOULOGNE (France).