Veit, a frequent industry speaker, and his co-panelists from Duke Medicine, Harvard University and Duke University Health System IRB, will discuss the practical implications and ethical considerations for multisite clinical trials conducted in a global setting during their session titled “Globalization of Clinical Research: Emerging Issues for Sponsors, Academic Research.” The panelists will provide strategies for sponsors, Academic Research Organizations and IRBs to work collaboratively to ensure the quality of global clinical trials.
Copernicus Group is a key contributor to the symposium. In addition to Veit’s presentation, CGIRB Vice President and Chief Business Development Officer Bill Van Nostrand and Quality Management Director Yvonne Higgins are members of the symposium’s program committee. Higgins will also moderate a panel discussion titled “Certifying Investigators, Accrediting HRPPs & Qualifying Phase I Clinics.”
“Emerging issues in global clinical research is a key topic,” Veit said. “The collaboration between all involved parties needs to be consistent in order to improve efficiencies, obtain the best quality data and ensure the safety of human clinical trial subjects.”
The May 15 symposium will bring together speakers from industry, academia, government as well as researchers from other countries who will focus on the protection of human subjects participating in global clinical trials, streamlining processes and minimizing the challenges of multiregional clinical trials. The program includes speakers representing the U.S. Food and Drug Administration, Copernicus Group IRB, Sanofi, Yale University, Harvard Medical School, Duke University Medical Center and Celgene.
About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB (cgirb.com), established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010.
About the Drug Information Association (DIA)
The Drug Information Association (diahome.org) is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and wellbeing worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India and Beijing, China.
About Duke Clinical Research Institute (DCRI)
The Duke Clinical Research Institute (dcri.org), the world's largest academic clinical research organization, is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.