About Us | Parexel Baltimore

Due to COVID-19 and adherence to social distance practices, we are screening by appointment only.

What is a
Clinical Trial?

What is a Clinical Trial?

Before a medication or new device for treatment of medical issues is available to the public, the United States Food and Drug Administration (FDA) must review and approve the medication or device for public use. The FDA does this to learn more about the product and ensure that it is effective and safe.

To get FDA approval, the company that makes the medication or device must conduct clinical research trials.

The companies ask people to volunteer for clinical research trials. In these clinical trials, participants are given the investigational medication or device and evaluated by study doctors and staff members.

After clinical research studies are complete, the pharmaceutical company submits the study information to the FDA. The FDA reviews this information and decides if the investigational medication or device can become available to the public.

  • About our Clinical Unit

We are based within MedStar Harbor Hospital in South Baltimore. We are a private, 60-bed clinic.

Throughout the pandemic, we have a COVID-19 Response Plan in place, which defines the processes and responsibilities related to the prevention of a COVID-19 outbreak at our clinic, as well as the detection and management of potential/confirmed COVID-19 infection. In addition, our staff and participants are provided with PPE, symptom monitoring, sanitization, and more.

  • How do I qualify?

Every clinical trial has eligibility requirements related to your age, health, and reproductive status. You must meet all the eligibility requirements to take part in a trial.

If you see a trial that interests you and you meet the eligibility requirements, you can apply online to take part. After you’ve applied, a trial staff member will contact you to invite you to a screening visit. Your screening appointment will be for a specific clinical trial, as each trial will have its own eligibility requirements.

Screening Visit:

At this screening visit, you would meet with doctors and staff members at our clinic to discuss the trial and be assessed against the eligibility requirements. This visit typically takes between 2-4 hours to complete. During this visit, you will review the informed consent document (ICD). The ICD must be signed before any study procedures can be completed. Then, if you still want to participate and agree to sign the ICD, we will complete the screening assessments. Screening assessments can vary from study to study but typically include:

  • Reviews of your medical history
  • Physical exams
  • Vital signs measurements
  • Blood and urine sample collections
  • Questions about how you are feeling
  • Reviews of any medications you are taking

Following the visit, our staff will typically contact you within 5-7 days to review your screening visit results and confirm if you meet the eligibility criteria for the study. If you are eligible for the study, you will be provided instructions on how to continue with the study and the dates/times of your next visit.

  • What to expect

If you are eligible to participate in a trial, you’ll be asked to visit our clinic a set number of times (depending on the length and design of the trial). Your safety during the clinical trial is of primary importance to us. To ensure your safety, we will typically need to re-check your health status and other eligibility criteria when you are admitted to the clinic as well as during the clinical trial.

You may be asked to stay at our clinic overnight. If this is the case, you’ll be provided with a room and meals and have access to movies, TV, video games, board games, and computers with internet access.


During the trial clinic visits, trial doctors and staff members will evaluate your health and response to any medication you’ve been given and answer any questions you may have. Some tests and assessments they use may include:

  • Reviews of your medical history
  • Physical exams
  • Vital signs measurements
  • Blood and urine sample collections
  • Questions about how you are feeling
  • Reviews of any medications you are taking
  • Reviews of any side effects you may experience

We have standard Clinic Guidelines or “House Rules” which outline what types of items are permitted on the clinic, behavioral expectations, and more. This document will be reviewed with you at your screening visit.

Our clinic is staffed 24/7, so you will constantly be in touch with our employees throughout your stay.

  • Refer a Friend

When you select the Share This button, you will be directed to enter your friend or relative’s contact information and the study number. Your friend or relative will receive only one notification about the study.

If your friend or relative participates and is dosed in a clinical trial with us, we will pay you $50*, as a way of showing our appreciation for your efforts.

*Compensation only for registered volunteers who have completed a study.


If I qualify for a study, do I have to participate?

No, you do not have to participate. It is your decision whether you want to join a study.

What ID shall I bring to my screening appointment?

You are required to bring in federal or state-issued photo identification, for example, a passport, driver’s license, or State Identification Card.

Can I come and screen for two different studies?

You may only screen for one study at a time.

How long does a screening appointment last?

Typically, screening can take around 2-4hours.  If you’re comfortable proceeding to a consenting session, you will sign the Informed Consent Document with a staff member. Following consent, screening procedures will commence. The time for these depends on the specific screening procedures for the study.

Can you transfer my screening results from one study to another to save me from doing two screening visits?

You must attend an individual screening for each study. Each study has a different consent with varying assessments and blood/urine tests that are performed.

Can I bring my child to my screening visit?

We don’t allow participants to bring children to a screening appointment.

Do I get paid for screening and doing the clinical trial?

You will be compensated for your time and effort if you sign the study consent, and all payments are outlined in the Informed Consent Document. You will be paid for the screening visit if you sign the consent document. The only exception is you will not be paid for your screening visit if you test positive for drugs of abuse (recreational drugs), alcohol, nicotine (if applicable), and/or double enrolled in another study at another site.

If I pass screening and am eligible, will I definitely get dosed on a study?

We cannot guarantee a place on a study. When permitted, we try to fit participants into the next cohort if they are within the screening window.

What does a backup/alternate participant mean?

A ‘backup/alternate’ participant is someone who has passed all the screening criteria, is invited for the study admission, passes eligibility criteria on admission, but is not selected to participate in the study. The alternate is not dosed unless a confirmed participant drops out or is not eligible to be dosed at that planned admission. The alternate participant can usually leave the unit when dosing is complete for the confirmed participants. Alternate participants receive a pro-rated payment for the study days completed. You can find the payment details in the consent form.

Can my family or friends visit me when I stay in your clinical unit for overnight stays?

We do not standardly permit visitors. Additionally, while we are in the pandemic, we cannot accommodate visitors.

If I join a study, do I have to complete the study?

No, you are free to leave a study at any time and for any reason. However, if you leave a study, the study doctor or study staff may ask you some follow-ups questions, and you will not be allowed to re-join the study.

What if I decide I want to stop or withdraw from a clinical trial after I’ve signed an Informed Consent Document?

Participants are free to withdraw from a study at any time. This will not affect the standard of care you receive, or your legal rights.

How many follow-up visits are required?

It depends on the study. Some studies may require more follow-up visits than others. The study doctor or the study staff will review how many follow-up visits you may need to attend.

If I refer a friend for screening, will I get a referral bonus?

A referral bonus is available for specific populations and study designs. Make sure your referral provides your name when scheduling the appointment.

Can I get study medication outside of clinical research studies?

No, only study participants are eligible to receive study medication. This is because clinical research study medications are not available to the public.

Should I talk with my family, friends, and personal doctor before participating in a clinical research study?
It is always a good idea to discuss study participation with people you trust. Your personal doctor may also be able to discuss other treatment options with you.
Reviews of any medications you are taking
Reviews of any side effects you may experience
What type of room will I be staying in?

Our rooms contain 2-10 beds. Typically, you will be housed with other study participants. These are typical hospital-style rooms and beds with TV remote controls and a call light. There are bathrooms in each room and additional restrooms on the unit.

Do I need to provide my own toiletries and towel?

Toiletries and towels are provided at our unit. You may bring toiletries from home, but if they contain alcohol or any prohibited ingredients per the study, they will be confiscated and returned upon discharge. Disposable cutlery will be provided. Limit your luggage to two bags and avoid oversized items. Parexel will not be responsible for the loss or theft of personal items.

Is there a washing machine available to use?

A washer and dryer are available at the unit. The laundry schedule can be provided to you at the time of admission. Note the laundry service is not suitable for dry clean only items.

What meals are served at the unit?

Meals can vary based on study requirements. For example, some studies require you to consume high-fat meals. Please note that no outside food is allowed. This includes ordering food while staying on our unit.

Can I bring some snacks and food items with me?

Food and beverages of any kind from outside are not allowed during the in-house period of the study.

Can I have packages and mail items delivered to the unit?

Please arrange an alternative address for long in-house stays as outside deliveries are prohibited and will need to be checked and may be confiscated until discharge.

Where do I park for Visits?

Free parking is available in any of the visitor lots surrounding the hospital.

Will I be paid in installments or all at once?

The payment schedule will be available within the Informed Consent Document, and information will be provided by the staff.

How will I be paid for the clinical trial, and when will I receive my payment?

Compensation will be issued by payment cards. If you withdraw or are removed from the study before study completion for any reason, you will receive a pro-rated amount of compensation based on the visits you have completed. You must give your Social Security Number or Taxpayer Identification Number to receive payment.

Are there any side effects?

As with any drug, marketed or not, there is always a potential for side effects. Your safety and welfare are of primary importance within all our studies and throughout any procedures carried out. Information regarding any possible side effects of the study drug can be found in the Informed Consent Document.

How long do you keep my data, and is it confidential?

We will follow ethical and legal practices, and all information about you will be handled in confidence. Data storage timelines vary depending on the study sponsor, but data can be up to 25 years in some cases.

How long does it take for my blood results to be available?

Most blood results are available within 48 hours. However, some studies have specific tests which can take longer to report. Our staff will update you as soon as the results are reported. If requested, we can forward your blood results in a PDF file via mail or email.

I was a backup/alternate on the previous study, so does that mean I won’t be a backup/alternate next time?

There is no guarantee that you will not be a backup/alternate on any admission. Backups/alternates are selected based on results. If all results are within the study’s parameters, we then dose in the order of which you screened. We will do our best to ensure that backup participants can take part in another group of the study if possible.

What are recreational drugs?

“Recreational drugs” is a loose term that refers to legal and illegal drugs used without medical supervision. There are four categories of recreational drugs: analgesics, depressants, stimulants, and hallucinogens, which include but are not limited to cannabis, PCP, amphetamines, methamphetamines, and opiates. We test for all of these at screening and on admission to the unit.

What is WONCBP?

WONCBP means “women of non-childbearing potential.” This includes post-menopausal women (no menses usually 12 months or longer) or surgically sterile women.

How frequently can I take part in a clinical trial?

The wash-out period for each study drug is different. The time depends on the next study you wish to participate in and its’ specific exclusion criteria.

What is meant by the Wash-out/ Half-life of a study?

Wash-out periods are dependent on a study. We require a minimum of 30 days after the last dose before you may screen for another study. This is to ensure safety and no interaction between study drugs due to previous participation.

What happens if I’m not able to make an outpatient visit due to a planned holiday/vacation?

Participants are required to be available for all study visits. If you cannot attend the outpatient visits for one cohort, you will not participate. However, there may be later cohorts with suitable dates.

What is a chronic disease?

A long-term physical health condition (also known as a Chronic condition) is a health problem that requires ongoing management over years or decades. An example is arthritis.

What is a long-term illness?

A long-term physical health condition cannot currently be cured but can be controlled with the use of medication and/or other therapies. Diabetes is a good example.

What do you mean by serious injury or illness?

Serious injury means an injury or illness that results in permanent impairment of a bodily function or permanent damage to a body structure or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Is there a smoking room within the unit?

Smoking is not permitted within the hospital grounds and is not allowed for most studies.

I gave up smoking recently, can I participate in your trial asking for non-smokers?

It all depends on the inclusion/ exclusion criteria for each study.

I have a family member who works for your company, can they come to visit me?

If you are closely related to anyone who works for Parexel or the Sponsor, this would exclude you from screening/ taking part in studies.


Do I need to be vaccinated to participate in a study, and do I need proof of vaccination?

Not all studies require you to be fully vaccinated, and neither do we at Parexel. However, if you are vaccinated, we do need proof of vaccination when you come in for your screening visit.

Will I be protected against COVID or informed of a COVID breakout at the unit?

Parexel has a COVID response plan in place to ensure the safety of all staff and participants. If there is a positive case on site, we have measures to ensure that the virus does not spread. However, we cannot completely remove risks related to COVID.

Am I required to wear a mask?

We require masks on our clinic. If you are in the room with your roommate, you can remove the mask. However, your mask needs to remain on when walking around the unit or if a staff member enters the room.

Find out what some of our volunteers have to say about us.

  • Do you have more questions?
  • Why not give us a call where our team will be happy to answer your questions?

Do you have more questions?

Why not give us a call where our team will be happy to answer your questions?