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STUDY NO. 2459

STUDY NO. 2459

Demographic: Healthy Volunteers
Gender: Female/Male
Age Range: 18-59 years of age
Location: St. Louis, Missouri

Compensation: $2200

Study Duration

1 Screening Visit (2-3 hours)
2 Periods

 

Recreational Drug Use

N/A

Toll-Free

314-528-2220

Smoker/Non-Smoker

Non-smoker

Compensation

$ 2200

Study Schedule

Screening Session Ongoing
Qualification Session N/A
Study Sessions

Period I
Check-In: Sunday, August 8, 2021 3pm – 4pm
Check-Out: Wednesday, August 11, 2021 8am – 9am

Period II
Check-In: Sunday, August 15, 2021 3pm – 4pm
Check-Out: Wednesday, August 18, 2021 8am – 9am

Follow-Up Visit N/A

 

Here's Some Of
Our Achievements

30+

Regulatory Inspections

2,000+

Completed Trials

20+

Awards and Recognitions

Registration Form

STUDY NO. 2618 – Gr 1

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ALL YOUR QUESTIONS ANSWERED

REGISTRATION / PRE-SCREENING

If you’re interested in an upcoming trial or would like to be informed of future trials, you can contact our Recruiting Call Centre and register/prescreen with us. Upon completing your registration we will provide you with the details of the study and assess if you qualify for the study on a preliminary basis (pre-screening).

MEDICAL SCREENING

If you are deemed eligible during your pre-screening (preliminary) evaluation, we will schedule you for a screening appointment. During this visit, you will participate in an informed consent session as well as the following medical assessments/measurements (these may vary based on the study requirements): body mass index (BMI), electrocardiogram (ECG)*, blood pressure, heart rate, respiratory rate, body temperature, physical examination, medical history review, alcohol test, blood test(s), urine test(s).

*ECG: An ECG (electrocardiogram) records the electrical activity of your heart. It provides information about your heart rate and rhythm.

RESULTS UPDATE

If you are deemed eligible based on the results of your medical screening visit, you will contacted by the Results Coordinator. We will usually call you within 5 business days of your medical screening appointment. This may vary.

STUDY PARTICIPATION

If you are assigned to a study, you will need to be prepared for your visits. This requires you to be available for the study visits based on the dates and times listed in the study schedule, following the study restrictions and arriving at the site in a timely manner with your personal belongings.

COMPENSATION

You will receive the full study compensation upon completion of all the study visits. This compensation may be broken down into partial payments depending on the overall duration of the study. Penalties and deductions may be applied for lateness, missed visits or non-compliances (as outlined in the Informed Consent Form). The compensation is provided on a pro-rated basis (i.e. you will be compensated for all completed visits according to the payment schedule).

Packing List

Things You Can Bring

• Change of clothes (appropriate and comfortable for the study duration)

• Electronic gadgets (devices with image capturing capabilities, such as cell phones, laptops and tablets will have cameras covered with special tape for the duration of confinement)

• Personal grooming products

Things Not To Bring

• Comb/Brush

• Toothbrush

• Toothpaste (no whitening or tartar control toothpastes or toothpastes with medicinal ingredients)

What are early phase clinical trials?

Clinical Trials are divided into 4 phases.  Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.

The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects.  Phase 1 trials are conducted in healthy volunteers.

Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.

What is a clinical trial?

A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective.   In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.

What is an investigational drug?

An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:

  • If the drug is safe and effective.
  • How the drug might be used in that disease.
  • How much of the drug is needed.
  • Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?

In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.

Should I expect to experience any side-effects while doing studies?

As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.

Will I be compensated for doing a clinical study?

Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).

Are food and accommodation provided over the course of the trial?

Food – Clinical trials are conducted in a controlled setting which means that all food is provided and  trial volunteers receive standardised meals.  Individual meal plans or meal preferences cannot be provided.  If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial.    Please contact us to discuss any food issues.

Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender.  Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.

What is the length of a study and do I have to complete all the visits?

Details of the duration of a study can be found on the Volunteer Hub.

What is informed consent and how is it carried out?

Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF).  The ICF describes the clinical research study and the nature of the investigational product to be used, including:

  • Your rights and responsibilities as a study participant.
  • What you will be asked to do during study participation.
  • The potential risks that you should be aware of.

During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff.  You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.

Can I bring my own food?

All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video

When do I receive compensation for taking part in a study?

You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)

Where will I sleep during the clinical study?

We provide a clean, safe socially distance sleeping environment, in a dormitory of hotel room style. Watch video

What COVID-19 precautions are you taking?

The safety of our volunteers is a top priority. Learn more about the measures we are taking to create a safe environment for you.

Can I bring my own device?

Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.

Privacy

We respect and value the privacy of our volunteers. View our Privacy and Cookie Policy here.