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SYNCHRON RESEARCH
FAQ
and Information for volunteers
The
following information is general in nature. Conditions for participation
in any particular study may be different from the ones given here. Talk
to a recruiting executive to get information about a study you wish to
take part in.
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
?
Synchron shall pay you renumeration for the in convinience caused to you
as a participant for the study.
Besides, you are doing a social service of the highest quality by participating
in a study, because only after these medicines are proved as per their
claimed safety and efficacy (into you volunteers), they get the permission
to go to the market. In this way, you help to get 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 clinical
research department. They will be glad to take down your comments and
questions.
To
give future volunteers an idea of what they may expect from Synchron,
we are providing here some information on a typical study.
Can a woman volunteer participate in this study ?
Yes, Synchron also conducts studies in healthy women volunteers as well
as post menopausal women volunteers.
Male and Female volunteer studies are conducted seperately.
Opening the File
To take part in a study, you must first fill out a questionnaire. The
information gathered will enable Synchron 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 Synchron.
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
of weight, height, and body frame, urine test, blood sample, electrocardiogram,
and urine testing for drug of 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 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 Synchron. 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
In 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 in order to see how the medication is being absorbed in the
blood and how it is dissolving in the blood stream. 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 that remains in place for a pre-determined 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 time 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 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 Synchron, 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 cheque for the amount still owed. The total may vary between
Rs.2000 and Rs.5000, sometimes more.
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 feel 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
feel 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 Synchron’s policy on gathering information over the Internet
and the choices you have as a user.
Synchron 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 the
Synchron’s database.
Synchron 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.
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