ClinicalRM to Co-Present Regulatory Compliance Panel at MAGI
October 26, 2011, Las Vegas, NV – Clinical Research Management, (ClinicalRM) a full-service Contract Research Organization providing services for basic and applied research, clinical trials, and regulatory support, announced today its Senior Scientific Director, Dr. Jere M. Boyer, Ph.D., will co-present a panel titled Battle of Compliance: FDA vs. OHRP vs. ICH at the MAGI West Clinical Research Conference, October 23-26, 2011 in Las Vegas, NV. The panel will discuss the important differences in clinical research regulations, guidelines and guidances between the United States Food and Drug Administration (FDA), the United States Department of Health and Human Resources Office for Human Research Protections (OHRP), and the International Conference on Harmonization (ICH). MAGI is the Model Agreements and Guidelines International organization whose mission is to standardize best practices for clinical research operations, business, and regulatory compliance.
Dr. Boyer, a Certified IRB Manager (CIM), Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), and a Clinical Laboratory Director/Diplomat in Clinical Microbiology for the American Board of Bioanalysis, is an established speaker and author, with specific focus on the growing complexity of managing Human Subject Protection over the past decade.
“The MAGI conference presents a great forum for sharing our collective expertise in compliance across regulatory groups that affect clinical research management,” said Victoria Tifft, founder and CEO of ClinicalRM. Said Tifft, “Dr. Boyer is an expert on the topic of Human Subject Protection, and offers valuable insight into the accountability and execution of regulatory requirements in the clinical setting.”
Founded in 1992, ClinicalRM is a full service Contract Research Organization (CRO) specializing in preclinical, and Phase I to Phase IV clinical research, and product development for biologics, drugs, and devices. ClinicalRM’s regulatory knowledge is an integral part of their overall expertise, and is infused early in the study process, to efficiently and safely achieve FDA approval of new products. ClinicalRM prides itself on providing outstanding customer service and exceeding client expectations.
ClinicalRM supports its clients with a wide array of regulatory and sponsor services including program and project management, site selection and management, recruitment, clinical data management, safety oversight, statistical analysis and reporting, training, and education within the U.S. and around the globe. Our commercial, military, Federal and academic customers include: academic research institutions, NIH, Walter Reed Army Institute of Research, U.S. Army Medical Materiel Development Activity, U.S. Army Medical Research Institute of Infectious Diseases, and the Naval Medical Research Center. For more information, please go to: www.clinicalrm.com.