What is Bimo inspection?
What is Bimo inspection?
FDA’s Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research.
What is clinical inspection?
The purpose of inspecting clinical trials is to ensure that the trials meet the standards of Good Clinical Practice (GCP). This includes attention to the safety and integrity of trial subjects as well as good data quality.
What are three common FDA inspection findings for clinical investigators?
Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent FDA inspections.
What is a Bimo package?
In order to shorten the time for regulatory review of a new drug application (NDA) or biologic license application (BLA), more and more biotech and pharmaceutical companies prepare their Bioresearch Monitoring (BIMO) program packages as part of their initial submissions.
What do Bimo inspections cover?
What is a BIMO Inspection Like? A BIMO inspection has three purposes: to ensure human research participants’ rights, welfare, and safety, to determine the trial data’s accuracy and reliability, and to check for FDA regulatory compliance.
What does Bimo stand for?
BIMO
| Acronym | Definition |
|---|---|
| BIMO | Benign Idiopathic Macro-Orchidism |
What are regulatory inspections?
The purpose of regulatory inspections is to ensure that operations at these establishments are carried out in accordance with approved standards, norms, and guidelines and are in compliance with the national medical products legislation and regulations.
Why was Bimo created?
The BIMO Program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals, as well as, to provide for protection of the rights and welfare of the thousands of human subjects involved in FDA regulated research.
What are some of the agencies that conduct regulatory inspections?
A list of regulatory authorities would include, but not be limited to, the Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), New York State Department of Health (DOH), New York State Department of Environmental Conservation (DEC), federal and New York State Departments of …
What is the difference between FDA inspection and Bimo?
Most inspections are of clinical investigators, although hired contractors, Institutional Review Boards (IRBs) and nonclinical laboratories can also be subject to FDA inspection. BIMO inspections are entirely different from manufacturing inspections, which are more a common type of FDA inspection.
Are your site contractors ready for a Bimo inspection?
Sponsors need to ensure that their own files and those of their site contractors are ready at all times for a BIMO inspection. The most effective and efficient way a sponsor can help sites and contractors to be ready is by setting standards for inspection readiness. Key measures include:
Bioresearch Monitoring Program Information FDA’s Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research.
What is the role of the sponsor during a Bimo inspection?
Clinical Investigator Inspections Sponsor and CRO assistance to sites during a BIMO inspection helps ensure that site personnel feel well-supported and that they are able to act with confidence, ultimately contributing to a successful inspection.