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Author - Kavan Palangappa

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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 Releases PointCross 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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PointCross Drug Safety Information Management Suite

PointCross Life Sciences' DSIMS is a suite of software applications, repositories, tools, viewers, customizable workflows and stage-gated processes, and enabling technologies for accessing and managing nonclinical study data for researchers, toxicologists, reviewers, and regulatory reporting staff. DSIMS has a hub-and-spoke architecture for safety data. The hub is the NSDR repository, which has, at its...

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What does SEND Readiness mean for your company? – Webinar

Watch the replay of this webinar held on June 27: What does SEND Readiness mean for your company The FDA will soon require drug companies to transmit their nonclinical data submissions in standardized electronic formats like SEND. This will fundamentally impact workflows and data management within drug companies and CROs, and will require nonclinical toxicologists to...

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Enhancing Drug Development with Tox Vision ++

PointCross Life Scienecs ToxVision++ is a viewer that extends the reach and power of the original ToxVision viewer to provide new ways to visualize, compare, and evaluate nonclinical study data in a single, standards-based environment. In a single tool, ToxVIsion++ reseolves how GLP data is received, stored, displayed, charted, extracted, reported, and how basic...

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Guarding Your Drug Safety Blind Spots

Hosted Webinar: DSEC Panel Discussion: Search, Analytics and SEND: Guarding Your Drug Safety Blind Spots Sponsored by PointCross Life Sciences The FDA has announced its intent to mandate nonclinical data submissions in standardized formats like SEND. Consequently, Agency reviewers expect to be spending more time on data analysis and detection of potential safety signals across studies....

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Enhancing Drug Safety with Tox Vision

ToxVision is the first viewer designed to automate the visualizing and normalizing of study data; ensuring the safety of drugs submitted for regulatory approval. Developed by PointCross Life Sciences, in collaboration with the FDA, Toxvision reads SEND data, making it easier for you to spot important signals and trends among a huge volume of...

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Study Data Integration & Search (SDIS™) Demo

PointCross Life Sciences SDIS is the first solution of its kind that closes a major gap in the nonclinical phase of the R&D lifecycle. SDIS creates an instantly searchable resource of all nonclinical study and assay data for BioPharma companies and regulatory agencies.

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PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services

Press Releases PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services FOSTER CITY, Calif., Oct. 3, 2011 PRNewswire PointCross Life Sciences, Inc. has announced that it has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the U.S. Food and Drug Administration to provide an integrated off-the-shelf software environment comprising of...

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Streamline Study Data Integration with SD

PointCross Life Sciences Study Data Integration and Search solution for the Biotech and Pharmaceutical industry provides a one-stop "Data-to-Insights" environment for nonclinical scientists to evaluate safety and efficacy indicators and biomarkers across normalized study data spanning internal and external sources, and global research sites.

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