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        ORA Program Areas

Office of Bioresearch Monitoring Operations (OBIMO)

                        
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          Office of Bioresearch Monitoring Operations (OBIMO)ORA Program Areas Office of Bioresearch Monitoring Operations (OBIMO)
  	
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The Office of Bioresearch Monitoring Operations (OBIMO), within the Office of Regulatory Affairs (ORA), is responsible for conducting inspections of clinical and nonclinical research conducted in support of marketing applications for FDA regulated products across all centers.

BIMO inspections focus on:

Ensuring the protection of trial participants involved in clinical research
	Studies are conducted according to applicable regulations
	The reliability of data submitted in applications to FDAThe BIMO program includes Postmarketing Adverse Drug Experience (PADE) and Risk Evaluation and Mitigation Strategies (REMS) inspections as part of the portfolio.

OBIMO's Mission

OBIMO's highly skilled, collaborative, and agile workforce ensures research subjects are protected and the data used to support FDA decisions is reliable.

What We Do

Domestic and foreign inspections of regulated entities conducting clinical and nonclinical research
	Inspections of drug establishments for compliance with PADE and REMS requirements
	Training and outreach to industry and academia
	Collaboration with international regulatory partnersWho We Are

Leadership Biographies
	Our PeopleAccomplishments

BIMO Inspection MetricsReport a Problem

VAERS 
Vaccine Adverse Effects Reporting System


MedWatch 
MedWatch: The FDA Safety Information and Adverse Event Reporting Program


Clinical Trials Complaints  
Reporting Complaints Related to FDA-Regulated Clinical Trials


Upcoming Events

03/20/2024-03/21/2024 - FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference(In-Person | Anaheim, CA)
	06/18/2024-06/20/2024 - FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference (Virtual)
	11/06/2024-11/07/2024 - FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference (In-Person | New Orleans, LA)Previous Events
	FDA Sponsor-Investigator Virtual Conference - 03/07/2023 - 03/09/2023
	FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference - 03/21/2023 - 03/22/2023
	FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference - 06/13/2023 - 03/15/2023
	FDA Sponsor-Investigator Virtual Conference

Additional Resources

Related BIMO Pages
	FDA Bioresearch Monitoring Information
	Bioresearch Monitoring Program (BIMO) Compliance Programs
	Clinical Trials and Human Subject Protection

                                                                                  Content current as of:
      12/27/2023Office of Bioresearch Monitoring Operations (OBIMO)                
                          

                        OBIMO Leadership & Staff
 
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