Navigation Links
PointCross Life Sciences' SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA's Upcoming e-Data Submission Mandate
Date:3/11/2013

FOSTER CITY, Calif., 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 for the Exchange of Nonclinical Data.  This will enable reviewers to analyze all the studies across species in a submission, and to detect weak or important toxicity signals in the data. To help Biopharma companies and their CROs prepare for such regulatory analytics, PointCross Life Sciences announces the immediate availability of its SENDBox™ and SEND-as-a-Service™ offerings.

Biopharma companies and CROs can use the SENDBox™ to assemble data from GLP validated data collection systems, transform them into SEND, and view them before submission.  SENDBox is offered with tools to meet Computer Systems Validation requirements.  It is available as an Enterprise solution behind company firewalls or as a Cloud-hosted service.  SENDBox is based on and compatible with DSIMS®, the engine behind the FDA's SEND-compliant Nonclinical Information Management System (NIMS).  NIMS helps the Agency to better evaluate the safety impact of drugs and improve reviewer efficiency.

SEND-as-a-Service is a Cloud-hosted offering intended for sponsors and CROs who simply wish to outsource the packaging of their disparate datasets, current or past, into SEND.  This service converts their data into SEND ready packages for submission or for analyzing their data in the same way as reviewers.

According to Dr. Shree Nath , VP of PointCross Life Sciences, "The Biopharma industry is moving quickly to become ready for the FDA's upcoming e-data submission directive.  Three top Sponsor companies have selected PointCross to deliver their SEND implementations after a careful evaluation of other providers.  Clients now have the flexibility of deploying the SENDBox solution and assembling SEND datasets themselves, or have our experts do it for them through SEND-as-a-Service.  These new offerings complement our proven DSIMS solution and provide large, mid-size and small Biopharma companies with options that best fit with their business needs."

About PointCross Life Sciences, Inc.

PointCross Life Sciences, Inc. is a global provider of Big Data analytics, data store and translational informatics solutions and services for safety detection across large, disparate, and weakly structured datasets.  Our offerings are used by researchers and reviewers involved with drug development, and are available behind the Enterprise firewall or on the Cloud.  Our clients include several global Biopharma companies as well as the FDA. PointCross Life Sciences is a wholly owned subsidiary of PointCross, Inc.

Contact
Dr. Shree Nath , VP, 
PointCross Life Sciences, Inc. 
1291 E. Hillsdale Blvd., Suite 304
Foster City, CA 94404 
1-866-468-1900 or get_SENDReady@pointcross.com
www.pointcrosslifesciences.com


'/>"/>
SOURCE PointCross Life Sciences, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. For International Life Sciences, Biotech and Pharmaceutical Events, Top Executives Turn to Global Information
2. Sangamo BioSciences Announces Presentation At The Barclays Global Healthcare Conference
3. Particle Sciences and NETZSCH Premier Technologies Enter into Collaboration
4. Dr. Joachim Schorr (PhD) zum Chief Scientific Officer von Caris Life Sciences bestellt
5. Joachim Schorr, PhD, Named Chief Scientific Officer at Caris Life Sciences
6. Presage Biosciences Announces Strategic Research Alliance with Celgene Corporation
7. Heptares to Present at the 6th Annual European Life Sciences CEO Forum (5-6 March)
8. Sangamo BioSciences Announces Presentation At 33rd Annual Cowen And Company Health Care Conference
9. Neurocrine Biosciences To Present At The Cowen And Company 33rd Annual Health Care Conference
10. BioDelivery Sciences to Host Buprenorphine Investor and Analyst Event
11. London Health Sciences Centre Announces Firsts in Treatment Option for Blood Circulation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... 2016 Story Highlights: ... within the health care industry is causing providers to ... , Deloitte offers a suite of solutions for health ... efficient cost optimization: labor resource analysis, revenue cycle optimization ... better outcomes and better economics ...
(Date:6/24/2016)... Dublin - ... " Global Markets for Spectroscopy Equipment" report ... This report focuses on the global market of ... applications in various applications. The report deals with spectroscopy ... industries: pharmaceutical and biotechnology, food and beverage, and environmental ...
(Date:6/24/2016)... , June 24, 2016 Research and ... Market for Companion Diagnostic Tests" report to their offering. ... for Companion Diagnostics The World Market for ... personalized medicine diagnostics. Market analysis in the report includes the ... Market (In Vitro Diagnostic Kits) by Region (N. America, EU, ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever ... Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation ... as home to some of the world’s leading providers of cereal and other breakfast ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet ... product that was developed to enhance the health of felines. The formula is all-natural ... two main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
Breaking Medicine News(10 mins):