Phases of a Clinical Study
		What is a Bioequivalence Study?
		What is a Phase 1 Study?
		How is a Study Designed?
		How Does Participation On-Study Work?
		Medical Exam
		Am I Eligible to Participate in a Study?
		Participate in a Study
		What Happens Once I am Admitted On-Study?
		What Should I Know About Consent Forms?
		What should I know about the medication being administered?
		What happens after the medication is administered?

Phases of a Clinical Study
Four clinical phases are conducted to develop a new medication. Each phase has its own objectives and requirements.

At Anapharm, we specialize in Bioequivalence and Phase 1 studies.

What is a Bioequivalence Study?
A bioequivalence study is a clinical trial that seeks to compare a medication produced by two different companies. One of the two medications is usually already being sold commercially, whereas the other is not.

What is a Phase 1 Study?
Once a drug compound has gone through preclinical testing, it is then ready to be administered in human beings. This testing is usually conducted in a small group (20 to 100) of healthy volunteers. The main objective of this type of study is to determine the safe dosage range at which a drug can be administered, the method of absorption and the elimination of the drug by the human body.

How is a Study Designed?
Once data is made available from our clients, our professional protocol writers, alongside our medical team, evaluate the needs and requests put forward by our clients. Once this data has been evaluated, our team of experts puts together a protocol indicating how the study will be conducted, which is then submitted to an independent review committee (IRB) and Health Canada. The study may only continue once the protocol has been approved by these external bodies. The protocol includes inclusion and exclusion criteria for the study. Only participants that meet the inclusion criteria will be admitted on a specific study.

How Does Participation On-Study Work?
First, you must complete the following information request form at: www.anapharm.com and then click on Study Participants Needed and select a site. Then select a study number. You must complete the BMI section in order to advance to next step which will permit you to complete the information request form. One of our recruitment experts will contact you over the next 48 hours or at the time specified on your request. Once all of your questions have been answered, and you would like to participate in a study, you will then be given an appointment to meet with our team of medical professionals to be given a thorough medical exam. The medical exam is similar to the kind of examination you receive at your doctor’s office. The information can also be made available to your doctor, if you wish.

Once the results have been received, you will then be notified if your profile corresponds to a particular study.


Medical Exam
The purpose of the medical exam is to verify your health and confirm that your participation in the proposed study is suitable. A doctor will check your weight, height, medical history, urine and blood tests, electrocardiogram and drug test results. At that time, you will also receive specific information about the nature of the study, possible side effects, the procedure and the dates of the study along with the dates for return visits. All of this information will be included on an Informed Consent Form that you can bring home with you. The medical staff will explain the Informed Consent Form and will answer all your questions before you participate in the given study. You may withdraw from a study at any time. You must though advise the medical staff on hand before leaving a study.

Am I Eligible to Participate in a Study?
All clinical trials have different inclusion and exclusion requirements. You may be ineligible for some studies, depending on their specific criteria. Participants, who are taking certain types of medication or have a medical history, are pregnant or breast-feeding may be excluded from a study. Other characteristics that may exclude you from a study is your participation in another study within the past 30 days or more (depending on type of study), drug or alcohol abuse or allergies to specific components in the tested drug.

Participate in a Study
You will be notified before entering in a study of special requirements or information depending on the study design. You may be asked to stop eating or drinking certain types of foods and beverages before your arrival at the clinic. These requirements may vary depending on the type of study. You will then be admitted in one of our clinics for usually two separate stays between 24 to 48 hours. The length of your stay will vary depending on the type of study. Based on the study design, the procedures involve taking medications and having blood and urine samples taken. After your stay, short follow-up visits may be necessary to study the long-term distribution of the studied medication in your body.

What Happens Once I am Admitted On-Study?
Depending on the type of study you participate in, you may be required to stay overnight in one of our clinics. Overnight stays usually last between 24 to 48 hours at a time and return visits usually last up to one hour or so. A stay is a confinement period where you will not be allowed to leave the premises for a predetermined length of time. You will be advised in advance of this length of time.

Our clinics are composed of shared sleeping areas with bunk beds. There are usually no more than six people per room. Each clinic is equipped with full bathrooms. Although it is strongly recommended to bring your own personal toiletries (towel, soap, shampoo, toothbrush, toothpaste, etc.) on-study, some of these items may be confiscated upon your arrival due to specific ingredients in the products. Any confiscated items will be returned to you at the end of your stay. We also have movie and game rooms to make your stay more enjoyable. Meals are prepared and delivered to our clinics by our approved caterer.

What Should I Know About Consent Forms?
All regulatory bodies request that study participants sign a consent form before commencing a study. By giving your consent, you understand and accept that there may be certain risks involved by participating in the study. This does not release our organization, our health professionals or our study staff from the responsibility we have in ensuring your safety and in providing ethical and professional care. Ensuring safety and providing professional care are of utmost important to us. We require that all of our employees respect the highest ethical standards set by the industry and by ourselves in order to conduct clinical studies and provide services with the highest level of integrity possible. When reading the consent form, all participants are made aware of the study details and risks. You are free to ask any questions you may have pertaining to a specific study. If you have read and understood the consent form and have received sufficient answers to your questions but you still don’t feel comfortable proceeding, you are entitled to withdraw from the study process at anytime.

What should I know about the medication being administered?
Study participants will take the study medication at a specific time, generally between 6:30 and 9:00 am. The dosage of the medication is predetermined by the sponsor and approved by an Independent Ethics Committee with final approval from Health Authorities.

What happens after the medication is administered?
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. There are usually between 15 and 23 blood samples taken per period (which usually includes one length of stay and subsequent return visits). The number of blood samples may vary according to the medication. If allowed by the research protocol (a document that describes the study details), we may use a catheter to collect blood samples. A catheter 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 study participants the discomfort of multiple blood sample collections. If your veins are sensitive, you may request to participate in a study that uses catheters or a study in which urine samples are collected. If a catheter is not allowed on the study, blood samples will be obtained by drawing blood with a needle.

For many years, many people around the world have participated in clinical studies which have helped in advancing scientific and medical knowledge of new drug therapies. Without their precious collaboration, many people would not be leading healthy longer lives. In some cases, volunteers have helped extend the lives of loves ones battling life threatening diseases and in others, to overcome serious or chronically illnesses.