Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development companies. With the most comprehensive portfolio of preclinical, clinical development and commercialization services, Covance provides industry-leading services, the world’s largest central laboratory network, and a global team of clinical research and commercialization experts.
With clinical research units throughout the US and Europe, we enroll people to participate in clinical research studies to test new investigational products, and approved medications for new treatments. Covance Clinical Research Units are part of the Phase I/IIa drug development portion of Covance.
What We Do Covance carries out clinical research studies on behalf of the world's leading pharmaceutical and biotechnology organizations. As more drugs are being discovered, more people are needed to participate in clinical research studies.
Conduct of Studies Clinical research studies at Covance are conducted by a group of medically trained staff, including doctors and nurses, who monitor your safety during your participation.
Worldwide drug authorities have regulations to protect clinical research study participants and standards for how trials are conducted. It is required that participants are told what the purpose of the study is, what will happen during the study, risks and benefits of study participation, and background information on the investigational medication, including other studies involving the medication. An independent ethics board reviews the study, including all documents a participant will read and sign to make sure appropriate safeguards are in place. Study participation is always 100% voluntary from start to finish.
Types of Studies Clinical research studies are classified into four phases defined by worldwide authorities.
Phase I studies, including First-In-Human studies, are conducted in a small number of healthy participants to determine safety and tolerability. These studies test how drugs are absorbed into the body, as well as the amount of time the drug stays in the body. Safety of the drug and side effects are evaluated at varying dose levels. Additionally, interactions among multiple drugs, equivalence of a generic drug to a marketed drug and the effect of food on how the drug moves through the body may be studied.
Phase II studies also involve a limited number of participants and help provide an early indication for whether the drug shows promise in treating the condition for which it is being developed. These studies involve participants who have mild-to-moderate forms of the condition the drug is designed to treat, but who are otherwise healthy. Examples include:
People with diabetes, asthma and high blood pressure Healthy post menopausal women Healthy elderly
Phase III studies include thousands of participants with the disease or medical condition the drug is being developed to treat. These studies determine safety and effectiveness. They may compare the study drug to a current marketed treatment. Healthy individuals may participate in Phase III studies for smoking cessation, insomnia, vaccinations, weight loss, etc.
Phase IV studies involve further testing in large numbers of individuals after the product is released on the market.
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