As a CRO, Anapharm’s successes, and the reputation it has established with pharmaceutical companies worldwide, is largely due to its ability to recruit volunteers and to offer them conditions that meet the most stringent safety standards.
To give future volunteers an idea of what they may expect from Anapharm, below is some information about a typical study.
» Creating a Personal File
To take part in a clinical study, you must first contact a study recruiter to provide information about your medical history. The information that you provide will allow Anapharm to create your personal profile and offer you studies that match this profile. A file number will also be assigned to you and will be used to identify you whenever you contact Anapharm.
» Assessing the Candidate
Once you have been added to our database, study recruiters will be able to identify studies that match your profile and availability. The recruiters will then arrange for you to take a medical exam and sign an Informed Consent Form (a form where you grant your consent to participate in a clinical study). You will then meet with a physician who will assess your health by performing a general examination that includes: measuring your weight, height, and body frame, performing a urine test, collecting a blood sample and taking part in an electrocardiogram and street-drug urine testing. You may also be asked to partake in an alcohol breath test. By taking part in this medical examination, we are striving to ensure that your health will not be endangered in any way, while also ensuring that your physical condition presents no factors that may alter the results for a study in which you may be asked to participate.
» Selecting the Candidate
If the results of your medical exam are satisfactory, one of our screening staff will contact you to confirm whether you are interested in participating in a given study. If the number of available volunteers should exceed our needs for a study, we will try to find another study that meets your needs. Volunteer participation is essential to our success and we will do everything to make it possible for you to participate in a study.
» Steps in a Study
Once you have been accepted for a study, you will go through the following steps:
|
| | Complying with Restrictions
Before showing up for your first length of stay, you will have to comply with certain restrictions as required by the study. Your recruiter will notify you of these restrictions in a timely manner. Restrictions are imposed to protect your safety and to ensure nothing will alter the results of assessments performed during the study.
|
| | Check In
On the first day of the study, you will check in at the agreed-upon time and place, usually between 4 and 6 p.m., for your orientation. You will be asked to sign an Informed Consent Form, a document that provides an overall view of the study and its implications. The contents of the Informed Consent Form will be explained to you. An inspection of your belongings will be performed during the welcoming session. 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 Anapharm premises. The medication is usually administered the following morning.
|
| | Rules to be Followed
The selection officer will inform you of the rules to be followed when he/she confirms your participation in a study.
|
| | Staff
The study will be carried out under the supervision of a complete and competent team of medical personnel. An attending physician will be available at all times in the event that a study participant has an abnormal reaction to the medication. Although the risk of this happening is low, it is possible, and we are ready to deal with this possibility at any time.
|
| | Living Conditions
During the course of the study, all volunteers must adhere to a pre-determined diet. The amount of food and liquids is determined in advance. There may be a critical meal during your study, which is a meal where you have to eat everything within a certain period of time. If you have any dietary intolerance, food allergies, or other special needs, tell your study recruiter.
All volunteers must adhere to the established schedule and you will have to go to bed at a set time, usually around 11 p.m. The wake-up call is generally around 6 a.m.
During the study, you will have plenty of free time for watching movies, playing board games, reading, doing personal work, or just relaxing. You can also bring your cellphone and laptop computer, if you wish.
|
| | Taking the Medication
You will have to take the study medication at a specific time, generally between 6:30 and 9:00 am. Often the prescribed dose is less than the dose that is administered to people who are ill, in order to minimize any possible side effects.
|
| | Collecting Blood Samples
After the medication has been taken, we will collect blood samples at regular intervals in order to see how the medication is being absorbed and dissolved in the blood stream. In general, there will be between 15 and 23 blood samples taken per period (which usually includes one length of stay and subsequent return visits). This number may vary according to the medication. If allowed by the research protocol (a document that describes study details), we may use a catheter, which is 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 a needle each time. Catheters are used to spare you the discomfort of multiple blood sample collections. If your veins are more sensitive than the average, you can tell the study recruiter that you would rather participate in a study that uses catheters or a study in which urine samples are collected. If a cathether is not allowed, blood samples will be obtained by drawing blood with a needle.
|
| | Check Out
You may check out either 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 will collect blood samples. The visits are usually early in the morning, between 6:30 and 9:00 a.m., to coincide with the time at which you received the study medication. Occasionally, there may be an evening return visit.
» Compensatory Indemnity
Our volunteers always receive a compensatory indemnity for their study participation. This amount is calculated in terms of the time spent at Anapharm, the number of return visits and, of course, the proportion of the study that you have completed. An amount is given to you after each length of stay, and a final cheque will be given at the very end of the study to cover the remaining amount that is due. The total usually varies between $300 and $2,000, and can sometimes be more.
» Complying with Restrictions
Each study has restrictions that must be adhered to. The criteria for each study varies. Check with a study recruiter to see whether your specific situation matches our selection criteria.
» Side Effects
While participating in a study, you may experience a side effect (also referred to as an adverse event) after taking the medication. Our experience demonstrates that most of our volunteers do not experience any side effects. The reason for this is simple, as our selection process is extremely rigorous. Our volunteers must be healthy and they will undergo a series of tests to ascertain their current medical status. You will be informed of the results of your medical exam in the event that we find anything of concern.
To minimize the possibility of any side effects, we usually administer a lesser dose than what is given to a person who is actually being treated with the medication. Any possible side effects therefore are those that are associated with a regular use of the medication. Although you will only be taking a few doses, you may experience some of these effects and the intensity can vary depending on the medication and the person taking it.
Our qualified staff members would be pleased to answer any questions that you may have about side effects.
|
» Privacy Policy for Internet-based Volunteer Recruiting
Below is Anapharm’s policy for gathering information over the Internet and the choices you have as a user.
Anapharm helps you to select studies that may be of interest to you. However, since we are conscious of the fact that your information is confidential, we have developed several security guidelines in order to protect your privacy.
| | Your file will only be kept in our database if you give us permission to contact you when clinical studies matching your profile become available.
You may, at any time, change or remove any personal information that is kept in the Anapharm database.
Anapharm will not contact you via e-mail if you do not want us to.
Statistics generated from our database will ensure the confidentiality of volunteer identities. As well, no personal information will be retraceable to specific subjects when preparing statistical reports. |
Our website provides links to other websites. However, these organizations are independent of Anapharm and we provide these links as a service to you. Anapharm Inc. cannot be held responsible for the privacy policies of these sites or their content.
Users will be informed of any changes to this website, including any changes to our privacy policy. It is up to the user, however, to read over the policy and keep abreast of changes. All comments are welcome.