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Author - Kavan Palangappa

PointCross Testing

PointCross and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug Development

Xbiom™ and iOmics™ integration arcs across nonclinical, clinical and genomic biomarkers for targeted therapeutic drug development and stratified patient selection Foster City, CA, April 20, 2015 /PRNewswire/ — PointCross Life Sciences today announced a strategic partnership with InterpretOmics Pvt. Ltd. to provide an integrated Big Data and globally accessible environment for genomic interpretation and analysis...

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NIMS Version 2.5 for SEND released to the FDA, Now Available for Industry

NIMS enables faster, deeper and more insightful regulatory review of nonclinical study data for safety signal detection and analysis   Silver Spring, MD, March 12, 2015/ PRNewswire PointCross Life Sciences today announced that the FDA has accepted NIMS version 2.5 for operational use to review nonclinical CDISC SEND data that accompany NDA, BLA and IND drug applications....

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PointCross announces SEND-ASSURE for Data Consistency in Submissions to the FDA

SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions Silver Spring, MD, March 9, 2015/ PRNewswire PointCross Life Sciences today announced the launch of its SEND-ASSURE audit solution to help pharmaceutical companies avoid the consequences of submitting standardized nonclinical data that is inconsistent with their study reports. CDISC SEND standardized data is required...

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FDA awards IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats

FDA awards $20M IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats   FOSTER CITY, Calif., Sept. 26, 2013 /PRNewswire PointCross Life Sciences, Inc. announced that it has been awarded an IDIQ contract with a cap of $20 Million by the U.S. Food and Drug Administration...

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PointCross Life Sciences Opens New Office in Silver Spring, MD for Data Standardization of Nonclinical Studies

PointCross Life Sciences Opens New Office in Silver Spring, Maryland for Data Standardization of Nonclinical Studies FOSTER CITY, CA, July 9, 2013 PRNewswire Extending its recently announced Data Standardization Service, PointCross Life Sciences announced that it has opened a new center in Silver Spring, MD, USA where studies submitted by sponsors to the FDA in PDF...

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PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions

PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions FOSTER CITY, CA, June 6, 2013 PRNewswire PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDA’s NIMS...

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PointCross Life Sciences’ SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s Upcoming e-Data Submission Mandate

Press ReleasesPointCross Life Sciences’ SEND Box and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s Upcoming e-Data Submission Mandate FOSTER CITY, CA, March 11, 2013 PRNewswire As a result of PDUFA V, the FDA will soon require Biopharma companies to submit their nonclinical study data in standardized electronic formats such as CDISC SEND, the Standard...

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