You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Each year, the FDA publishes its Bioresearch Monitoring (BIMO) metric findings to provide insight on audit trends and significant violations. The BIMO program’s inspectional data includes Clinical Investigative Sites, Institutional Review Boards (IRBs), Sponsors/Monitors, Contract Research Organizations CROs), Bioequivalence, and Good Laboratory Practice Audits.
Topics: BIMO Metrics, FDA Warning Letters
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The Food and Drug Administration (FDA) released an updated Guidance for FDA Staff for Sponsors, Contract Research Organizations (CROs) and Monitors on April 19, 2017 as part of the Bioresearch Monitoring (BIMO) program. The updated version contains revisions to Part III, section D, which provides additional instructions to FDA investigators related to www.ClinicalTrials.gov reporting and registration requirements that came into effect on January 18, 2017 in 42 CFR Part 11.
Topics: BIMO Metrics, FDA, BIMO Guidance Manual
For the sixth year consecutive year, IMARC is presenting its Top 10 Warning Letter findings for your review.
Topics: BIMO Metrics, Top 10, FDA, Warning Letters
The FDA Bioresearch Monitoring Program (BIMO) was created to: “Protect the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical trials; Verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and To assess compliance with statutory requirements and FDA's regulations governing the conduct of clinical trials.” But, how exactly does FDA safeguard human subjects, ensure data integrity, and verify compliance with applicable standards?
Topics: BIMO Metrics, IMARC Research, FDA, Warning Letters