Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Ultimately, all applications are subject to review and approval by the US Food and Drug Administration (FDA).
At every stage of the process, it is Criterium’s mission to:
Criterium Inc conducts National and Multi-National Clinical Trials in a wide range of Therapeutic Areas. Our personnel have participated in over 500 studies. Here is a selected list of previous studies:
All Criterium Clients benefit from our efficient technology-based workflow. Field staff in the USA and internationally are supported by centralized Remote Study Management, Data Management, Statistical Analysis, and Programming Support services in Criterium’s New York headquarters.
Because of this strong support structure the data are locked sooner, allowing for statistical analysis, final reports and speedy submission of studies to the client and agencies. This enables us to set aggressive timelines, reduce costs and produce very high quality data when completing the clinical trial process.
Some of the specialized services Criterium provides include:
From the time it leaves the discovery laboratory until it is cleared by the U.S. Food and Drug Administration, a new drug typically follows a series of well-defined steps. Here's an overview of the process that all pharmaceutical companies must follow to file a new compound in the United States:
With experienced personnel including Board Certified Physicians in each region, Criterium clients benefit from our thorough understanding of the unique regulatory structures and specialized patient requirements of each country in which we work.
From the time it leaves the discovery laboratory until it is cleared
by the U.S. Food and Drug Administration, a new drug typically follows
a series of well-defined steps. Here's an overview of the process
that all pharmaceutical companies must follow to file a new compound
in the United States: