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:5/28/2015)... -- Quest Diagnostics Incorporated (NYSE: DGX ), the world,s ... is scheduled to speak at the Jefferies 2015 Global ... the company,s President and CEO, will discuss the company,s ... scheduled for Tuesday, June 2, 2015 at 8:00 a.m. ... live during the conference and will be available to ...
(Date:5/28/2015)... DUBLIN , May 27, 2015 /PRNewswire/ ... announced the addition of Jain PharmaBiotech,s new ... to their offering. An ... and biotechnology industries is anticipated. Nanotechnology will ... development - from formulations for optimal delivery ...
(Date:5/28/2015)... Research and Markets( http://www.researchandmarkets.com/research/6cg3zw/cell_therapy ) has ... "Cell Therapy - Technologies, Markets and Companies" ... describes and evaluates cell therapy technologies and methods, ... role in the practice of medicine. Hematopoietic stem ... marrow transplants. Role of cells in drug discovery ...
(Date:5/28/2015)... (PRWEB) May 28, 2015 The Academy of ... Model Aviation Day on August 15, 2015. National Model Aviation ... nation-wide and to introduce model flying to the general public. ... chartered clubs to participate in the celebration by hosting events ... to host National Model Aviation Day events. View our ...
Breaking Biology Technology:Quest Diagnostics to Speak at the Jefferies 2015 Global Healthcare Conference 2Global Nanobiotechnology Market 2015-2024 - Applications, Markets and Companies 2Global Nanobiotechnology Market 2015-2024 - Applications, Markets and Companies 3Global Cell Therapy Market 2015-2020 - Technologies, Markets and Companies 2Model flying pilots celebrate the Academy of Model Aeronautics Foundation’s Third Annual National Model Aviation Day 2
... Reaffirms Full Year OutlookORANGE COUNTY, Calif., April 28 ... a leading developer, manufacturer and marketer of products ... today first quarter ended March 31, 2009 results. ... down 5.3%, or flat in constant currency terms. ...
... the availability of Stock Alerts on stocks making news today. ... parading up the charts. So how does swine flu affect ... (BCRX, AVII, DVAX) reeling from influenza news that should be ... .Today,s Stock Alerts include: Hemispherx Biopharma ...
... to as ,Mini IVF, or ,Minimal Stimulation IVF, at ... are now weighing in at FertilityTies.com ... also called "Mini IVF" or "Minimal Stimulation IVF." FertilityTies ... providing 24-7-365 support on fertility matters, connecting members with ...
Cached Biology Technology:Beckman Coulter Announces First Quarter 2009 Results 2Beckman Coulter Announces First Quarter 2009 Results 3Beckman Coulter Announces First Quarter 2009 Results 4Beckman Coulter Announces First Quarter 2009 Results 5Beckman Coulter Announces First Quarter 2009 Results 6Beckman Coulter Announces First Quarter 2009 Results 7Beckman Coulter Announces First Quarter 2009 Results 8Beckman Coulter Announces First Quarter 2009 Results 9Beckman Coulter Announces First Quarter 2009 Results 10Beckman Coulter Announces First Quarter 2009 Results 11Beckman Coulter Announces First Quarter 2009 Results 12Beckman Coulter Announces First Quarter 2009 Results 13Beckman Coulter Announces First Quarter 2009 Results 14Beckman Coulter Announces First Quarter 2009 Results 15Beckman Coulter Announces First Quarter 2009 Results 16Beckman Coulter Announces First Quarter 2009 Results 17Beckman Coulter Announces First Quarter 2009 Results 18Beckman Coulter Announces First Quarter 2009 Results 19Beckman Coulter Announces First Quarter 2009 Results 20Beckman Coulter Announces First Quarter 2009 Results 21Beckman Coulter Announces First Quarter 2009 Results 22Beckman Coulter Announces First Quarter 2009 Results 23Beckman Coulter Announces First Quarter 2009 Results 24Beckman Coulter Announces First Quarter 2009 Results 25Beckman Coulter Announces First Quarter 2009 Results 26Beckman Coulter Announces First Quarter 2009 Results 27Beckman Coulter Announces First Quarter 2009 Results 28Beckman Coulter Announces First Quarter 2009 Results 29Antiviral Drugmaker Shares Soar as Swine Flu Spreads; Beacon Equity Issues Stock Alerts on: HEB, GNBT, BCRX, DVAX, NVAX, SVA 2Antiviral Drugmaker Shares Soar as Swine Flu Spreads; Beacon Equity Issues Stock Alerts on: HEB, GNBT, BCRX, DVAX, NVAX, SVA 3Under the Microscope: 'Micro IVF' 2Under the Microscope: 'Micro IVF' 3
(Date:5/11/2015)... JOSE, Calif. , May 11, 2015 /PRNewswire/ ... developer of human interface solutions, today announced the ... Vice President and Chief Financial Officer, reporting to ... Ali replaces Synaptics, current Chief Financial Officer, ... December 2014. Mr. Ali brings ...
(Date:5/8/2015)... May 8, 2015 Synaptics Inc. (NASDAQ: SYNA ... that members of the executive management team will present at ... Technology, Media and Telecom Conference Date: May 18, 2015 ... Boston, MA Cowen and Company ... 2:45pm ET Location: The New York Palace Hotel, ...
(Date:4/27/2015)... 27, 2015  For more than four decades, AUVSI,s ... been the premier worldwide event for the unmanned land, ... must-attend event for any local, national, or trade news ... commercial markets and current applications of unmanned technologies. The ... projected $48 billion industry, and how it will soon ...
Breaking Biology News(10 mins):Synaptics Appoints Wajid Ali as Senior Vice President and Chief Financial Officer 2Synaptics to Present at Upcoming Investor Conferences 2UNMANNED SYSTEMS 2015: Largest International Conference and Trade Show for the Drone and Unmanned Technology Industry 2UNMANNED SYSTEMS 2015: Largest International Conference and Trade Show for the Drone and Unmanned Technology Industry 3UNMANNED SYSTEMS 2015: Largest International Conference and Trade Show for the Drone and Unmanned Technology Industry 4UNMANNED SYSTEMS 2015: Largest International Conference and Trade Show for the Drone and Unmanned Technology Industry 5
... access publishing program that offers immediate publication followed by ... after publication. Following recent approval by the National Library ... this peer review process will now be listed in ... F1000Research ,s acceptance by the NLM Selections group ...
... Health, science and genetics reporters are invited to register ... Genomics (ACMG) Annual Clinical Genetics Meeting, March 19-23, 2013 ... Whole Genome/Exome Sequencing, the focus of the ACMG Meeting ... in healthcare today and in the future. The conference ...
... A new method of establishing hair and eye colour from ... from ancient human remains, finds a new study published in ... HIrisPlex DNA analysis system was able to reconstruct hair and ... the Polish General Wladyslaw Sikorski (1881 to 1943) confirming his ...
Cached Biology News:
... Based Oligonucleotide) Genome Set and MEEBO (Mouse ... contain a collection of open source oligo ... allowing interrogation of thousands of genes. Developed ... University and UCSF, the sets enable the ...
odz, odd Oz/ten-m homolog 1 [Source:RefSeq_peptide;Acc:NP_055068] Antigen: Recombinant Protein Epitope Signature Tag (PrEST)....
Rabbit polyclonal to FANCE ( Abpromise for all tested applications). entrezGeneID: 2178 SwissProtID: Q9HB96...
Rabbit polyclonal to NIRF ( Abpromise for all tested applications). Antigen: Synthetic peptide derived from residues 186-235 of human NIRF. Entrez Gene ID: 115426 Swiss Protein ID: Q96PU...
Biology Products: