All you need to know.
Here are the answers to the most common questions about our research studies. If you need to know more call the location near you.
What is Novum?
Novum is a Contract Research Organization (CRO) that provides research services to the worldwide pharmaceutical industry. For over 40 years, Novum has been considered one of the world’s leaders in the conduct of clinical trials. Novum has completed over 3,000 studies for more than 300 pharmaceutical companies.
What types of studies do you conduct?
We conduct three main types of studies: Outpatient, Topical/Skin and PK-Bioequivalence. [Other study types may be conducted and vary by location.] These studies can be as brief as two days or may last as long as three to six weeks. Some may require overnight stays and blood draws and others will not.
These types of studies typically test transdermal (e.g. patch) products that are applied directly to the skin. Transdermal products may cause skin irritation (e.g. redness, swelling, itching or burning). The patch itself may also cause skin irritation. Skin irritation studies are used to test the degree of irritation caused by these products and are normally conducted on an outpatient basis. Participants in outpatient studies do not stay overnight with Novum. These studies usually last between three to six weeks, and participants come to Novum on prescheduled visit days and times for study assessments. Each scheduled visit usually lasts about one hour and usually does not require blood collections.
These types of studies test topical (applied to the skin surface) corticosteroids (e.g. hydrocortisone). Corticosteroid products cause blanching (whitening) of the microvasculature (very small blood vessels) of the skin. This blanching response is thought to be related to the amount of drug entering the skin. Participants in these studies will have test drug products (e.g., lotions, ointments, creams or tapes) applied to their forearms for specific amounts of time and then the products will be removed. The blanching responses will be measured using a device called a chromameter (color measurement) at regular intervals during the study. Participants will usually stay at Novum one overnight during these studies, and they do not normally require any blood collections.
These types of studies typically compare two drug products, for example, a commercially available Brand product (e.g. Tylenol®) and a potential to-be-marketed generic product (e.g. acetaminophen). Pharmacokinetic (PK) studies are usually performed in which each of the drug products is administered in a cross-over design (each participant will receive each drug product separately over the course of the study) to volunteer participants who are in general good health. After receiving a drug product, blood samples are taken at regular intervals and then tested for the drug concentration. For these types of studies, participants will usually stay at Novum on two separate occasions for one or more overnights on each occasion. Sometimes, there may be return visits required for additional drug concentration blood collections after being released from the clinic.
What kinds of drugs do you test?
We test newly developed medications as well as new formulations and generic equivalents of medications already on the market. These can either be prescription or over-the-counter medications and could include tablets, capsules, nasal sprays, patches, skin creams, etc.
What is the procedure for participating in a study?
After you’ve inquired by phone or through the website about being a study participant, you will be added to our participant database. A Novum recruiter will then contact you and ask you a few personal and general health questions. If you meet the criteria for one of our clinical studies, we will schedule your visit to the clinic for a screening appointment.
If you qualify for a clinical study after screening, we will contact you to let you know. Remember, your participation in any clinical research study is voluntary and you are free to withdraw at any time.
If you are participating in a study with overnight stays (inpatient study), you must be available to remain in the clinic for the entire period of the study. These studies vary in length. We have medical staff on site to ensure your safety and comfort during your entire stay. All meals, accommodations, entertainment and recreation facilities are provided to you at the clinic. If you are participating in a study that will require you to fast (not eat) for a short period of time during your stay, you will be informed when setting a screening appointment and reviewed again during the informed consent process in screening. You must remain in the clinic for the duration of the study and return for all scheduled appointments to complete the study and receive your final payment for participation.
If you are participating in a study without overnight stays (outpatient study), you will have scheduled return appointments based on the study needs. You must meet all scheduled return appointments to complete the study and receive your final payment for participation.
What happens during the screening appointment?
The screening visit will include meeting with a medical staff member who will explain to you the details about the clinical research study and any known side effects associated with the drug being tested. After you have had time to read through the study information and all of your questions have been answered, we will ask you to sign the Informed Consent Form for the study.
A physical exam will be conducted at no cost to you to make sure you meet the study requirements. We will be checking:
Height, weight, temperature and blood pressure
Heart trace (electrocardiogram – EKG)
Blood and urine analysis, including a drug screen and pregnancy test; other tests may be done if required for the study.
All the information you provide during your screening visit will be kept strictly confidential. If any of the screening results require follow-up from a health care provider, a Novum staff member will call you. If you decide to have additional evaluations and/or treatment, these will be at your own expense.
Do I have to have the particular condition that the drug is used to treat in order to participate in a study?
No, in most of our studies we are testing for absorption of the drug and we require healthy participants.
Will I be paid?
Yes, our participants are compensated based upon the length and complexity of the study. If the study requires several visits you may be given a progress payment at the end of each visit. The bulk of the money will be paid at the end of the study.
Do study participants stay overnight?
Most of our studies involve an overnight stay. Some stays require only one night with us. Frequently, studies involve a number of overnight stays that extend over two or more visits. For example, you would arrive on a Friday evening and would leave on a Sunday morning for a total of two weekends.
Will meals be provided during my stay?
Yes. Novum will provide all meals to you that we get catered in from various local restaurants. This includes breakfast, lunch, dinner and an evening snack.
What can I do during free time?
You will have lots of time to do many different activities. Clinics have an assortment of items for you to enjoy, including televisions, board games, video game players and computers. [Activities may vary by location.] You can catch up on your reading, do homework or just play cards. Feel free to bring your personal tablet, laptop orsmartphone to enjoy our high-speed Wi-Fi.
Can I leave the facility after checking in?
If you want to complete the study, once you are checked into a study you cannot leave to go to work or perform other outside activities. You can, of course, leave at any time but you will only be compensated for the time of the study you complete.
I am a smoker; can I smoke during the study?
Many of our studies are for non-tobacco users only. However, if tobacco use is allowed it will be limited to just a few special times each day and only in designated areas.
Do I have to give blood?
While many studies do require small blood samples to be taken, we also regularly have studies where no blood samples are required. Studies that require blood sampling may vary by location.
How do I get started?
You can either call us directly at one of the toll free numbers listed on the Clinics/Studies page or simply Register Now on this website and one of our recruiters will contact you.