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