Copernicus Group IRB (CGIRB), a leading independent institutional review board, led May 15’s “Creating a Global Clinical Trial Platform: Partnering for Synergy” symposium in collaboration with the Drug Information Association (DIA) and the Duke Clinical Research Institute (DCRI).
In addition to CGIRB staff members, speakers included representatives from top academic institutions Yale, Harvard and Duke, industry-leading corporations Merck, Sanofi and Celgene, and the Food and Drug Administration (FDA).
“The symposium attracted a unique group of panelists,” said CGIRB Vice President and Chief Business Development Officer Bill Van Nostrand. “For me, as a member of the program committee, it was a remarkable experience to work with the panelists and refine the theme for each session. The blending of unique experiences and perspectives enhanced the overarching theme of collaboration.”
Yvonne Higgins, CGIRB’s Director of Quality Management, served as the symposium’s committee co-chairperson. She was instrumental in building the event’s roster of world-renowned speakers.
“It was inspiring to work with each of the panelists,” said Higgins, who also moderated a panel discussion on investigator certification, accreditation of human research protection programs HRPPs and qualification standards Phase 1 clinics. “Having a group with this much experience from so many respected organizations created a platform for innovation and new ideas to be shared.
The symposium’s question and answer sections were particularly stimulating. Attendees posed questions about the hurdles they face in conducting multi-regional clinical trials; and the expert panelists offered advice and solutions which created an exciting atmosphere of partnership.”
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.