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The US is world-renowned for excellent standards of care, extremely high levels of training and expertise in specialist and critical healthcare with unsurpassed investment in clinical research.

Each clinical trial in the U.S. has to be approved and monitored by an Institutional Review Board (IRB) to ensure that any risks are minimised and would justify the potential benefits. An IRB consists of an independent group of physicians, statisticians, community advocates, and other parties who guarantee that a clinical trial is ethical and protects the rights of the study participants. Ultimately, each application is subject to review and approval by the US Food and Drug Administration (FDA).

orphan reach can help you realize the following advantages to conducting your clinical trial in North America:

• Rapid study start-up as a result of the IRB structure in place.

• Specialized / Targeted Research from the vast pediatric and critical care expertise of US investigators.

• Effective Patient Recruitment to meet the FDA requirements for inclusion of US populations.

orphan reach has the knowledge and expertise to successfully deliver studies across North America.

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