USC-CHLA Institute for Pediatric Clinical Research Selects DataLabs as Exclusive Electronic Clinical Data Management Provider

May 25, 2005

Applied Clinical Trials

DataLabs technology will be used to support and conduct multi-site clinical trials for the testing of novel therapies for childhood diseases.

IRVINE, Calif. --May 25, 2005--DataLabs, an innovative developer of Internet-based applications for clinical development, announced today that it has been selected by the USC-CHLA Institute for Pediatric Clinical Research (IPCR) as the exclusive provider of electronic clinical data management technology.

The Institute for Pediatric Clinical Research is a combined effort of the Keck School of Medicine of the University of Southern California and Childrens Hospital Los Angeles.

The USC-CHLA IPCR will use DataLabs' technology to support and conduct multi-site clinical trials for the testing of novel therapies for childhood diseases.

Over a period of several months, IPCR evaluated a number of solutions for human clinical trial data management. An evaluation team was formed that represented various IPCR functions, including clinical research, computer science, regulatory affairs and quality assurance.

Dr. Eric Bubbers, IPCR Director of Regulatory Affairs, said that IPCR selected DataLabs because of the following key factors:

  • DataLabs electronic clinical data management solution is intuitive, easy to use.
  • DataLabs solutions enable HIPAA compliance, are CDISC compatible, and have advanced audit trail capabilities.
  • DataLabs business model provides flexibility for expandability and scaling options.
  • DataLabs technology easily integrates with USC and Childrens Hospital's existing technology systems and adheres to all internal IT requirements.

"IPCR's objective is to facilitate and expedite human testing of novel therapies for childhood diseases," said Dr. Bubbers. "We will use DataLabs' technology to help us facilitate this process by enabling rapid and compliant multi-site clinical studies that support consistent and comprehensive recording of clinical data, thorough analysis of study outcomes, real-time patient evaluations and timely reporting to regulatory agencies."

As with many other academic research institutions, IPCR conducts highly complex trials involving patients with multiple treatment paths. DataLabsXC, based on Microsoft platform technology, XML Web services and the CDISC ODM standard, easily adapts to each institution's complex operating procedures and integrates easily with their existing technology systems. As a result, DataLabs is committed to providing IPCR and the academic research world with clinical data management tools that will greatly enhance their clinical trial processes and accommodate all of their complex requirements.

"For decades, USC and Childrens Hospital have been among the world's leading institutions for pediatric care and clinical research," said DataLabs' President Jim Langford. "We are pleased that USC and Childrens Hospital are leveraging DataLabs' technologies to build upon its world-class legacy. Our relationship with the IPCR is a perfect example of how DataLabsXC can add value for the academic research community."

Two other clinical consortia with which IPCR collaborates, Therapeutic Advances in Childhood Leukemia (TACL) and New Approaches to Neuroblastoma Therapy (NANT), will also be using DataLabs eCDM solutions.

About USC-CHLA Institute for Pediatric Clinical Research
The USC-CHLA Institute of Pediatric Clinical Research combines resources from both the Keck School of Medicine of the University of Southern California and Childrens Hospital Los Angeles to establish the most active and productive pediatric clinical trials program in the United States. The program is designed to find the best means to diagnose, treat, and prevent pediatric disease and to promote child and adolescent health. For more information, please visit http://chla.usc.edu and http://ipcr.us.

About DataLabs
DataLabs is an innovative developer of Internet-based applications for clinical development that helps the biopharmaceutical industry accelerate clinical trials with proven software for study design, data capture and data management. Based on Microsoft platform technology, XML Web services and CDISC ODM standards, the DataLabsXC product suite adapts to established operating procedures and integrates easily with existing technology systems. As a result, DataLabsXC customers enjoy a low total cost of ownership and high return on investment. Major pharmaceutical companies, government entities, healthcare organizations and contract research organizations are currently realizing time and cost savings using DataLabsXC. DataLabs, a Microsoft Certified Partner, is based in Irvine, Calif. with East Coast offices in Pennsylvania. For more information, please visit www.datalabs.com.