Are your clinical trials ready for an audit, inspection and/or site monitoring visit now? If your organization is running clinical trials, you know that being audit ready is essential to meet Good Clinical Practice (GCP)
There has been a sharp increase in the demand for n of 1 trials. Many institutions are vying to become the dominant leader in this space because of the numerous benefits. However, significant challenges are
Institutional review boards (IRBs) are ethics review committees that ensure human research subjects’ rights are protected, as well as the rights of the patients who ultimately benefit from the research. Operating under US federal regulations, state laws, and institutional policies, the IRB has the authority to approve, require modification to, and disapprove research. IRBs are an important part of regulatory efforts and their approval is required for all human research. Here’s a quick overview of IRBs and the expectations for working with them.
Approximately 80 percent of clinical research sites polled in a recent Complion, Inc.-sponsored survey said the costs and burden associated with administrative tasks for a single study has increased over the past two years, continuing a five-year upward trend.
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