PC-LDM ENSURES COMPLIANCE WITH THE SEND FORMAT FOR DATA EXCHANGE AND

ELECTRONIC SUBMISSIONS

    FOSTER CITY, Calif., Oct. 4 /PRNewswire/ -- PointCross announced today
 the release of its PC-LDM(TM) Suite that allows Pharmaceutical and
 Biotechnology companies to instantly become compliant with SEND (Standard
 for Exchange of Non-Clinical Data), a CDISC (Clinical Data Interchange
 Standards Consortium) standard. FDA is anticipating that SEND will replace
 its current paper or PDF submission formats as indicated in the Federal
 Register Notice for a Regulatory SEND Pilot
 (http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-19468.pdf).
     Besides SEND compliance, PC-LDM enables global companies to plan the
 pipeline of studies, exercise control over the conduct of studies, improve
 study quality, and gain visibility into study progress internally or at a
 CRO in a highly secure manner. It provides a single, secure environment to
 orchestrate multi-party workflows, and stakeholder interactions within an
 individual company, or across the extended enterprise including CROs.
     PC-LDM is available either as a SaaS (Software-as-a-Service) model, or
 deployed within the enterprise.
     "The FDA yesterday announced a Regulatory pilot to test the SEND
 standard and tools for submission and review of nonclinical data including
 animal toxicology and carcinogenicity data," said Seema Handu, Ph.D., of
 PointCross. "As the FDA moves towards data-centric electronic submissions,
 it is essential for sponsor companies to manage their study data throughout
 the lifecycle of a drug in a standard consistent manner," Dr. Handu added.
 Dr. Handu has led the SEND Team, a CDISC Working Committee, since its
 inception in 2002.
     "PC-LDM will enable sponsor companies to meet FDA's requirements around
 SEND as well as other formats that may be required by other agencies," said
 Shree Nath, Ph.D. "PC-LDM's Semantic Data Exchanger allows data from legacy
 and on-going studies to be readily available for analysis and data mining,
 study comparison across similar chemical structures, decision making, and
 knowledge re-use. This is invaluable considering the amount of information
 loss due to legacy applications being retired, data currently locked
 permanently in documents, and inconsistent use of scientific terms by
 different CROs and individual scientists," added Dr. Nath.
     PointCross' PC-LDM offering is built on Orchestra(TM), a scalable,
 secure SOA platform that provides core capabilities for defining,
 executing, analyzing and interpreting pre-clinical studies. PC-LDM includes
 vendor neutral XML-based Operational Data Models (ODMs) for all
 pre-clinical study types. It allows data exchange across industry standard
 applications and formats.
     About PointCross
     PointCross (http://www.pointcross.com) provides advanced strategic
 business solutions implemented on its Orchestra(TM) platform to
 knowledge-intensive industries including Pharmaceutical R&D and Upstream
 Oil and Gas. Besides PC-LDM, PointCross' IDDS (Integrated Drug Development
 Suite) includes other solutions for specific business processes within the
 R&D chain such as Lead Optimization, CMC Workbench, and Portfolio/Resource
 Management. Our customers have realized excellent ROIs and IRRs by using
 our solutions.
 
 

SOURCE PointCross