Animal health studies submitted to the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) for product approval have a multipart process from study design to report submission. Ensuring data quality along this process is critical for successful submission and product approval.

This seminar provided a comprehensive look at data quality with a dialogue from many perspectives on the subject, including sponsor, CRO, academic, clinical trial, study monitoring, as well as the CVM.

Major topics included:

• Building high quality data
• Study logistics, data collection and data management
• Quality assurance oversight and monitoring
• Reporting and submitting data

This was the third seminar in the series.

Seminar documents

Ensuring Data Quality in Animal Health Sponsor Perspective

Annette Kenser , Quality Assurance Expert, Bayer U.S. LLC

Heather Raszka, Principal Specialist, RDQA, Boehringer Ingelheim Animal Health

Damon Bradley, Research & Regulatory Systems Data Manager, Bayer U.S. LLC

Ensuring Quality in Animal Health Studies Clinical Investigator and Study Monitor Perspectives

Karen Bond, senior clinical trials manager, Product Development, Dechra Development LLC

Roger Sifferman, investigating veterinarian, BPVH Clinical Trials

ONADE’s Data Quality Review

Ana Lazo, Quality Assurance Specialist, Office of New Animal Drug Evaluation, Center for Veterinary Medicine

K-State Olathe Animal Health Regulatory Affairs Data Quality (CRO perspective)

Kelly Lechtenberg, president and owner, Midwest Veterinary Services, Central State Research Center, Veterinary and Biomedical Research Center, and Timber Creek Veterinary Hospital

Ensuring Data Quality in Animal Health Studies

David Renter, professor of epidemiology and director for the Center for Outcomes Research and Epidemiology, College of Veterinary Medicine, Kansas State University

Ensuring Data Quality in Animal Health Studies

Speakers