Clinical Research USA
Criterium’s Headquarters is
located at 358 Broadway, Suite
201, Saratoga Springs,
NY 12866, USA. The telephone number is + 1 518-583-0095.
Our California branch office is located
at 734 Silver Spur Road, Suite 203
Rolling Hills Estates, CA 90274. The telephone number
is Phone: + 1 310-377-7517.
Our US offices are in charge of coordinating
and overseeing our clinical research in the US and around
the world.
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:
- Provide Quality Solutions
that meet or exceed the clients’ expectations
for the entire clinical-research process, from initial
planning to approval, which can be customized to fit
each client’s specific needs.
- Reduce Costs by
transforming "traditional" monitoring tasks
through proprietary technologies without the additional
purchase of expensive computer hardware and software.
- Accelerate Timelines through
the use of proprietary tools for more rapid data collection
that can be used by sites and patients for direct
entry into study databases.
I) THERAPEUTIC EXPERTISE:
Criterium USA is currently conducting
National and Multi-National Clinical Trials in the following
Therapeutic Areas:
- Urology
- Dermatology
- Cardiovascular
- Cough/Cold
- Asthma
- Ophthalmology
- Infectious Disease (HIV)
Criterium personnel have participated
in over 500 studies providing a variety of services
including comprehensive clinical trial management. Below
is a list of past studies.
II) SERVICE EXPERTISE:
All Criterium Clients benefit from
our unique and efficient technology-based workflow structure.
Field staff in the USA are supported by centralized
services in Criterium’s Saratoga Springs, New
York headquarters where data-based Remote Study Management,
Data Management, Statistical Analysis, and Programming
Support are integrated to provide daily support to the
field team.
With experienced personnel (including
Board Certified Physicians) on the ground, Criterium
Clients benefit from our thorough understanding of the
unique regulatory structures and specialized patient
requirements of each country included in a clinical
trial. This enables us to set aggressive timelines,
reduce costs and produce very high quality data when
completing the clinical trial process in. Because of
the close working relationship with headquarters, the
data are locked very soon after the last patient completes,
facilitating statistical analysis, final report and
submission of studies to the client and agencies.
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.
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