Designing a study forces you to clarify your concepts and develop a goal. While challenging to consider all aspects of the process, the CRO can guide you, ensuring that you create a clinical study with relevant and reportable outcomes.
In preparing for submission to the Institutional Review Board (IRB), faculty members consult with the CRO staff for protocol development and to review their clinical research studies for operational feasibility.
An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.