RESEARCH TRIANGLE PARK, N.C. – JUNE 7, 2004 – Quintiles Transnational Corp. today announced that it has been certified as a CDISC Registered Solutions Provider for managing data submitted for the approval of new medicines.
CDISC – the Clinical Data Interchange Standards Consortium – has established standards on how data is collected, which types of data are collected and how the data is submitted to agencies that approve new medicines. CDISC certifies Registered Solutions Providers that it considers to be qualified consultants, system integrators and subject matter experts with sufficient knowledge and experience implementing the various CDISC standards. Quintiles is the first global provider of the full range of drug development and marketing services to be certified.
"Quintiles is already implementing CDISC Submission Data Standards (SDS) and laboratory data standards. This certification lets customers know that we can help them implement this standardized format, which should lead to more efficient review of regulatory submissions," said Larry Hauser, Vice President, Clinical Data Management, Quintiles North America. "The FDA supports these standards and is incorporating them in the development of a standard set of tools for the agency's medical reviewers. We can help customers benefit from the improved efficiency of the review process by submitting CDISC-compliant data."
"The latest version of SDS CDISC, version 3.1, is complex. Many companies will need to rely on the expertise of Registered Solutions Providers like Quintiles for their implementation," said Gary Walker, Senior Document Management Advisor for Quintiles. "Quintiles' team has developed a model that uses a mock clinical trial to illustrate an implementation of CDISC's standards, from data collection through submission. We're giving examples of what we've developed to CDISC so companies can better understand what's involved for this level of implementation."
In addition to developing the implementation model, Quintiles has contributed to the CDISC organization in a number of other ways including participation on the Industry Advisory Board, the CDISC Laboratory Data and Submissions Data Standards teams, as well as the European CDISC Coordinating Committee and Japan CDISC Group.
According to Ellen Morrow, Global SDS Implementation Team Leader for Quintiles, "Quintiles' collaboration with the CDISC SDS team has facilitated our ability to implement version 3.1 almost simultaneously with the rollout of this latest version as well as provide consulting to other companies wanting help with their own implementation."
CDISC also is an important tool in the development of real-time clinical trials, said Graham Bunn, Global Vice President, e-Clinical. "Quintiles is using CDISC as the integral data standards component of its e-Clinical initiative, which aims to deliver more integrated and proactive clinical trials for its customers," Bunn said.
CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. Quintiles is a founding sponsor of the consortium.
Quintiles helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Headquartered near Research Triangle Park, North Carolina, Quintiles has offices in 50 countries and is the world's leading pharmaceutical services organization. For more information visit the company's Web site at www.quintiles.com.