Clinical trials are research studies conducted on behalf of pharmaceutical companies to help establish the safety and effectiveness of a new drug. At any one time, inVentiv Health clinical may be conducting a number of trials studying a variety of different drugs or medical devices.
The following information outlines specifically inVentiv Health clinical's work within Phase I and bioequivalence studies. Phase I refers to new drugs that have been through years of testing in animals and are now ready to be administered to people. The main objective of this type of study is to determine the safe dosage range at which a drug can be administered and the methods of absorption and elimination of the drug by the body. A bioequivalence study seeks to prove that two medications are exactly the same, although they are produced by two different companies, as in the case of generic drugs.
Open studies — for which we are currently recruiting participants — are posted on our website. Once a potential participant has opened a file and has been accepted, he/she will be able to review available studies and choose the ones for which he/she qualifies and that fit his/her interests and availability.
The first step in the process is for potential participants to agree to participate in a clinical trial. All participants must sign a consent form before they can take part in a trial. This document describes precisely what the study is about, the expected outcomes, and the possible risks of participation. Any questions that participants may have can be discussed fully with our medical staff during that process. Also, if at any time a participant feels uncomfortable or no longer wish to participate in the study, he/she will be permitted to withdraw from the trial as long as the staff is notified prior to departure. This will not result in any penalty for participating in future studies.
Once participants have accepted to participate in the trial, a complete medical examination will be conducted to verify the participant’ health and eligibility for that study. A qualified medical team will check the vital signs, weight, and height, review the participants medical history, and conduct urine, blood, electrocardiogram, and drug tests. This information is entered into our database, allowing us to quickly match a participant with suitable trials. Personal information is kept confidential.
Each clinical trial has different requirements, so a potential participant may not be ineligible for some studies because of medical history or the medication that is being taken. Other characteristics that may exclude an individual from a study include recent participation in another study, drug or alcohol abuse, pregnancy, breast feeding or allergies to specific components in the tested drug.
How a study works
Controlling the environment of the study is critical to obtaining accurate data. Most studies involve periods in which participants must stay in our facility from a few hours or a few days to several weeks.
We have comfortable, dormitory-style facilities where participants can stay with other participants. We will provide all meals during the stay at our facilities. Depending on the type of study , participants will be asked to take the medication then provide varying quantities of blood and urine samples at specific times. When not actively involved in this process, participants will be free to read, study, listen to music, or take advantage of our games and movies.
After the stay, short follow-up visits may be necessary to determine the amount of time the compound remains in the body.
A word about safety
Ensuring the participant’s safety is our number one priority. The teams who administer the trials are composed of highly experienced physicians, registered nurses and qualified technicians, and the procedures they follow are rigorous. The drugs under consideration have already undergone extensive testing in the laboratory and in completely new drugs, in animals. The integrity of the data we will be gathering requires meticulous attention to detail, and rest assured we will provide it.