Raleigh, NC, USA, March 16, 2009—d-Wise Technologies is pleased to announce that Chris Decker will present a session at the Drug Information Association’s (DIA’s) 45th Annual Meeting (June 21-25, 2008; San Diego, CA).
The DIA Annual Meeting is the biopharmaceutical industry's largest, longest running, best-value, global, multidisciplinary event. This year's program offers learning opportunities for everyone and features the biggest names from industry, regulatory, and academia.
Chris Decker will deliver a presentation on the CDISC/FDA Integrated Data Pilot. At the beginning of 2008, CDISC released a Technical Road Map to provide an overview of the activities in the development and harmonization of current and future CDISC technical products over the next three years. One of the roadmap’s key objectives is to “execute pilots with regulatory authorities to gain a better understanding of the needs of regulators and industry”. The CDISC/FDA Integrated Data Pilot was initiated in October of 2007 with the mission of demonstrating that a patient data submission created using CDISC Harmonized Standards will meet the needs and expectations of FDA reviewers in conducting an integrated safety review of data from multiple studies and compounds. The goal of the pilot is to expand on the work of the SDTM/ADaM Pilot conducted from 2005 to 2007 and test the ability of CDISC standards to review integrated data.
During the course of the pilot the team has addressed a number of challenges with implementing the CDISC standards to review data across studies. This session will provide an overview of the Pilot including the mission, goals, objectives, an update of the progress, and the challenges faced with implementing standards.
The session will present a case study of experiences implementing the CDISC models and provide the industry with feedback on the real world use of standards for data integration.
About the Drug Information Association (DIA)
DIA serves more than 30,000 biopharmaceutical professionals from industry, academia, and regulatory agencies worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit www.diahome.org or call 215-442-6100.
About d-Wise Technologies
d-Wise is a technology consulting company with a focus in Health and Life Sciences. d-Wise specializes in custom solutions using SAS and related technologies. d-Wise has built SAS-based data warehouse and reporting systems for a variety of customers and have experience with both the data and systems related to clinical trials, health insurance, patient care, and genetics.
