FDA Grants Approval to a “Top- Five” Pharma – Based on ViPS MetaTrial EDC Technology
ViPS, Inc., a leader in business intelligence solutions for healthcare and major provider of clinical trial services for life sciences, today announced that the company’s life sciences division, ViPS BioMedical Services, has achieved a major milestone in the use of MetaTrial®, its electronic data capture (EDC) software for clinical trial data capture.
A “top-five” pharmaceutical company used data gathered via MetaTrial in a global phase III clinical trial in support of an application to the Federal Drug Administration (FDA), which formerly granted its approval.
Data was presented to the FDA in MetaTrial’s dynamic PDF files. These dynamic PDFs allowed reviewers to see clinical trial data in the context of the electronic case report forms (eCRFs) in which it was entered. The PDFs also allowed reviewers to see all of the options available in drop-down lists and a complete audit trail showing any changes made to the eCRFs in the course of the clinical trial.
Earlier during development of MetaTrial’s dynamic PDF utility, MetaTrial representatives met with FDA reviewers to ensure that the PDF files would be acceptable to the agency.
“This milestone reinforces MetaTrial’s position as a robust EDC system that meets regulatory requirements,” says Karen Borda, vice president and general manager of ViPS BioMedical Services. “MetaTrial’s ability to work online and offline was a vital factor in this trial because of Internet connectivity problems at some non-U.S. sites, particularly at critical stages during the trial. And our corporate emphasis on customer satisfaction meant that the ViPS team worked closely with the trial sponsor to ensure trial deadlines were met.”
About ViPS, Inc.
ViPS delivers innovative business intelligence that simplifies the business of health – providing advanced care, claims, risk and performance management solutions as well as fraud prevention and clinical trial solutions. A privately held firm headquartered in the Baltimore-Washington, DC metro area, the company operates three business units under the names ViPS Government Solutions, ViPS HealthPayer Solutions and ViPS BioMedical Services and serves commercial and government clients, from large health plans, major managed care organizations and global pharmaceutical organizations to leading federal agencies and contractors. For more information, visit www.vips.com . Email webinfo@vips.com or call 888-289-8477.
