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:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical ... innovative solutions for injectable drug administration, today shared the ... ID Adapter for improving the intradermal administration of polio ... Skin Vaccination Summit in May 2017 by Dr. ... Polio Department, World Health Organization (WHO), and recently published ...
(Date:10/4/2017)... 2017  According to the Centers for Disease Control and Prevention (CDC), ... PhysicianOne Urgent Care is helping communities across Massachusetts , ... by offering no-cost* flu shots through the end of the month. ... insurance regulations. ... get a flu shot is by the end of October, according to ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, the ... by Walgreens and pharmacy benefit manager Prime Therapeutics LLC ... brand, which included the unveiling of new signage at ... as well as at a few other company-owned facilities ... brand to patients, some of whom will begin to ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
(Date:10/12/2017)... ... ... Leading pediatric oncology experts at Children’s National Health System will join ... International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by Jeffrey Dome, ... at Children’s National, and Stephen P. Hunger, M.D., Chief of the Division of ...
(Date:10/12/2017)... ... 2017 , ... Health Literacy Innovations (HLI), creator of the ... the Cancer Patient Education Network (CPEN), an independent professional organization that shares best ... alliance. , As CPEN’s strategic partner, HLI will help support CPEN members ...
Breaking Medicine News(10 mins):