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Orphan disease clinical trials help with rare conditions .pdf


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Orphan disease clinical trials can help those with rare conditions
According to the United States Food and Drug Administration (FDA), an orphan
disease is a condition that affects less than 200,000 people across the country.
Well-known orphan diseases include cystic fibrosis, Tourette’s syndrome, and
Lou Gehrig’s disease. INC Research is a leader in orphan disease research, having
run more than 100 clinical trials in the field over the past 10 years.
Rare disease research is an incredibly specific field, but INC Research has the
experience and expertise to help you develop the next orphan drug. Our clients
are part of a rare disease clinical research network, and we work hard to ensure
that this research can be undertaken as smoothly as possible to ensure maximum
productivity.
Orphan diseases present a particular set of challenges for clinical trials as there
may only be a small number of patients in each country. In these cases, it is
essential to choose the right site for your trial so that patients can be brought in
easily and their needs effectively tended to.
INC Research helps researchers with site selection, patient identification,
logistics, operational strategy, and data management. The team develops an
individual strategy for each trial, so each client knows that they are getting a
bespoke service. After all, no two clinical trials are the same.
Another unique challenge is the high level of investment in a small number of
patients. INC Research staff are on hand to support patients and study
coordinators will manage them, as well as liaising closely with site staff to ensure
that every aspect of the trial runs smoothly.
One of the main ways that the company facilitates orphan disease research is
through the INC Research Rare Disease Consortium, which is designed to bring
together investigative sites, physicians, advocacy groups, thought leaders and
sponsors that are involved in the field. By bringing together all of those who work
in rare disease research, INC Research works to improve the patient experience
while also collecting quality clinical data.
Such a holistic approach to orphan disease research marks INC Research out
from its competitors and demonstrates a deep understanding of the issues
surrounding work in the field. If patients, orphan disease companies, and
researchers all have their specific needs attended to, the results can be
spectacular.
Wherever you are in the world, experienced INC Research staff members are on
hand to help. There are 390 staff members with rare disease experience in North

America alone and another 477 in the European Union. Asia Pacific is home to
118 experienced staffs, while Latin America boasts 64, and the MENA region has
13.
Clinical trials require a significant investment, and there is no denying that rare
disease research is a challenging area of work. INC Research has all of the skills
and expertise needed to ensure that your trial results in a satisfactory experience
for all of those involved.


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