CGIRB Vice President and Chief Business Development Officer Bill Van Nostrand and Quality Management Director Yvonne Higgins are collaborating with fellow committee members to create a program aimed at addressing the challenges involved in conducting global clinical trials including levels of protection and the diversity of regulations, requirements, and ethical issues that are unique to the conduct of clinical trials in a global setting at the “Creating a Global Clinical Trial Platform: Partnering for Synergy” symposium in Durham, N.C.
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.
“Our goal in organizing this program is to provide a forum for sharing and encouraging best standards in the ethical conduct of global clinical trials,” Higgins said. “The group of speakers and the agenda the program committee has assembled is impressive.”
Panelists will share their perspectives on ethical and resource responsibilities in a global setting,
the state of clinical research, how to conduct simultaneous global studies, certifying investigators, accrediting HRPPs and qualifying phase I clinics, globalization of clinical research and emerging issues for sponsors, academic research organizations & IRBs.
“At CGIRB, we always look for ways to partner and create innovative ways to improve efficiencies and consistency in human subject research protection,”
About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB, 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. For more information please visit http://www.cgirb.com
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