Navigation Links
FDA awards $20M IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats
Date:9/26/2013

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 to provide software development and life cycle management of NIMS (Nonclinical Information Management System) as well as to standardize current study submissions to enable reviews in NIMS. PointCross will standardize non-electronic submissions from PDF, non-standardized electronic and CDISC® SDTM formats into CDISC SEND or extended data representations for studies that do not fit within prevailing standards. New extensions and data models to be developed under this contract include MCM (Medical Counter Measures), efficacy studies, safety pharmacology, and reproductive toxicology. This contract will extend NIMS to meet the FDA's goals for better regulatory decision making and advancing computational sciences.

(Logo: http://photos.prnewswire.com/prnh/20120327/AQ77258LOGO)

The FDA acquired DSIMS® (Drug Safety Information Management Suite) from PointCross Life Sciences in October 2011 as the foundation for their NIMS application in an earlier contract. DSIMS™ includes study data repositories, analytics, and visualization of safety data and metadata for disparate types of studies and trials.

Highlighting the importance of this contract, Suresh Madhavan, CEO of PointCross said, "We believe the FDA's award reflects their continued trust in PointCross to help the Agency meet their rapidly changing needs in computational and regulatory sciences. We look forward to serving the industry by freeing the flow of standardized eData for safety, research, and improving time to market of drug products."

About PointCross Life Sciences, Inc.
PointCross Life Sciences, Inc. is a global provider of Big Data a
'/>"/>

SOURCE PointCross Life Sciences, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Dr. Alice Jacobs, CEO of IntelligentMDx, Named Best Entrepreneur in Eighth Annual Stevie® Awards for Women in Business
2. CSL Behring Awards LEAD Grant to Patient Organizations to Educate Constituents on State Insurance Exchanges
3. Sweet Success for Hosmac India Pvt. Ltd. at ET NOW-IndiaMART Leaders of Tomorrow Awards 2011
4. Elsevier Foundation Awards 2011 Grants to Advance Women in Science and Support Libraries in Developing Countries
5. Galien Foundation Announces 2012 Awards Program For Best Biopharmaceutical Products and Best Medical Technology
6. Lupus Research Institute Awards $3.6 Million for Novel Studies Driving Wide-Ranging New Science in Lupus
7. The 14th Annual LOréal-Unesco Awards or Women on Science: From March 26 to March 29, Paris Welcomes and Honours Tomorrows Scientific Talents
8. UBM Canon, the Global MedTech Authority, and the Medical Design Excellence Awards Announce Dean Kamen as the Presenter of the 2012 Lifetime Achievement Award
9. Trinity College Dublins Neuroscience and Bioengineering Programmes Receive Postgraduate Course of the Year Awards
10. aTyr Pharma Receives Industry Innovation Awards from TiE and San Diego Venture Group
11. The Scientist Magazine’s 2012 Multimedia Awards—Call for Entries
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... July 24, 2014 Research and Markets ... Cell Culture Market 2014-2018" report to their offering.  ... Cell culture is the in vitro growth of plant ... cell studies, and biopharmaceutical production. Cell culture is a ... culture instruments and cell culture consumables are necessary for ...
(Date:7/24/2014)... 24, 2014  CorMedix Inc. (NYSE MKT: CRMD), ... therapeutic products for the prevention and treatment of ... notice on July 18, 2014 from the NYSE ... the CorMedix plan to regain compliance with continued ... the NYSE-MKT is continuing the Company,s listing and ...
(Date:7/24/2014)... , July 24, 2014 WIRB-Copernicus Group ... regulatory and ethical review services for clinical research, ... Formerly a division of Richmond, VA ... leading biosafety and biosecurity consulting firm in ... addition, WCG,s biosafety division – WCG Biosafety™ – ...
(Date:7/24/2014)...  Spherix Incorporated (SPEX) -- an intellectual property development ... property, today announced that the Company will issue a ... on Monday, August 18, 2014 for shareholders. Management has ... Monday, August 18, 2014 to discuss the company,s progress ... Anthony Hayes . Following prepared remarks, ...
Breaking Biology Technology:Global Cell Culture Market 2014-2018: Key Vendors are Becton, Dickinson and Co, EMD, GE Healthcare, Lonza Group, Sigma Aldrich and Thermo Fisher Scientific 2CorMedix, Inc. Granted Extension of NYSE-MKT Listing 2CorMedix, Inc. Granted Extension of NYSE-MKT Listing 3WIRB-Copernicus Group Announces Acquisition of Alliance Biosciences; Executives Join WCG Biosafety Division 2WIRB-Copernicus Group Announces Acquisition of Alliance Biosciences; Executives Join WCG Biosafety Division 3Spherix Schedules Shareholder Update Call 2
... Inc. (Amex:,SGN) announced that it has filed its Form ... of trading of its common stock,on the American Stock ... trade on AMEX will be Friday, September 12, 2008.,Signalife ... for,quotation on both the Over-The-Counter Bulletin Board and the ...
... Takeda San Francisco Inc.,announced today that Gregory Landes, ... antibody research. Dr. Landes will be responsible for,directing ... Takeda,s antibody IND engine and center of excellence ... experience in the biopharmaceutical,industry and is a great ...
... Sept. 8 NovaVision today announced,that the company ... AdvaMed,2008: The MedTech Conference (http://www.advamed2008.com ), on ... the presentation, which falls in the "Next Generation" ... officer of,NovaVision, will address the increasing use of ...
Cached Biology Technology:Signalife Announces Anticipated Date of Transition to OTCBB 2Takeda San Francisco, Inc. Appoints Gregory Landes, Ph.D. Vice President of Antibody Research 2NovaVision CEO Named Presenter at the AdvaMed 2008 Conference 2
(Date:7/24/2014)... new study has identified two factors that characterize ... the production of highly qualified physics teachers. Specifically, ... champion physics teacher education in combination with institutional ... remain viable. Science, Technology, Engineering and Math (STEM) ... the study points the way for institutions seeking ...
(Date:7/24/2014)... 2014 Some sticky research out of York University ... certain species of toxic grass fungus: moose saliva (yes ... Biology Letters , "Ungulate saliva inhibits a grassendophyte mutualism" ... red fescue grass (which hosts a fungus called epichlo ... fungus growth and less toxicity. , "Plants have evolved ...
(Date:7/24/2014)... Albert Einstein College of Medicine of Yeshiva University ... Foundation for Parkinson,s Research to translate a basic science ... discovery project will test chemical compounds on a newly ... that acts on an underlying cause of the disease. ... people manage their symptoms, we are eager to stop ...
Breaking Biology News(10 mins):Creating sustainable STEM teacher preparation programs 2Moose drool inhibits growth of toxic fungus: York U research 2Albert Einstein College of Medicine receives grant from the Michael J. Fox Foundation to fund drug discovery project targeting Parkinson's 2Albert Einstein College of Medicine receives grant from the Michael J. Fox Foundation to fund drug discovery project targeting Parkinson's 3
... of the most recent, popular supplements for athletes looking to ... acid called L-arginine. The reason for its popularity ... physiology. "First, L-arginine is a precursor for nitric oxide ... may aid the delivery of important nutrients to working muscles ...
... published this month in the Journal of the American ... Science Center at San Antonio have pinpointed the cancer-fighting potential ... Susan Mooberry, Ph.D., leader of the Experimental Development Therapeutics Program ... of pharmacology at the UT Health Science Center, has been ...
... Researchers at King,s College London have discovered how one ... pave the way for less harmful pain relief medications to ... in the US and Asia as acetaminophen, is a widely-used ... as cold and flu remedies. Although discovered in the ...
Cached Biology News:L-arginine: Supplement tested on fit, athletic men shows no advantage 2L-arginine: Supplement tested on fit, athletic men shows no advantage 3Bat plant could give some cancers a devil of a time 2First study to reveal how paracetamol works could lead to less harmful pain relief medicines 2First study to reveal how paracetamol works could lead to less harmful pain relief medicines 3
...
...
Removes polysaccharide and phenolic inhibitors of PCR; yields DNA greater than 50 kb in length...
Sf9 Insect Cells (Frozen) in Max-XP Medium...
Biology Products: