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:7/2/2015)... ... July 02, 2015 , ... ... of surgical instruments in Orthopedics, announced today the acquisition of Turner Medical, ... largest provider of surgical instruments to the Spine Industry. The acquisition of Turner ...
(Date:7/1/2015)... Mass. , July 1, 2015   ... most frequently cited advantages of Otezla are its ... safety profile, as reported by surveyed rheumatologists. Otezla ... launched for the treatment of active psoriatic arthritis ... The current standard of care includes conventional oral ...
(Date:7/1/2015)... 1, 2015   Neuraltus Pharmaceuticals, Inc. , a ... groundbreaking drugs to treat neurodegenerative diseases such as ... Robert G. Miller , M.D., Director of the Forbes ... Pacific Medical Center in San Francisco, has been awarded ... million to help fund a Phase 2 clinical ...
(Date:7/1/2015)... , ... July 01, 2015 , ... A newly launched ... ideas to lower the barriers to innovation in life sciences R&D. The Pistoia Alliance ... two cash prizes of US$15,000 and a period of expert mentorship from a senior ...
Breaking Biology Technology:In'Tech Medical Acquires Turner Medical to Become a World Leader in Orthopedic Contract-Manufacturing 2In'Tech Medical Acquires Turner Medical to Become a World Leader in Orthopedic Contract-Manufacturing 3Surveyed Rheumatologists Report That Otezla's Oral Administration is its Single Greatest Advantage Over Currently Available Treatment Options 2Surveyed Rheumatologists Report That Otezla's Oral Administration is its Single Greatest Advantage Over Currently Available Treatment Options 3Investigator to Receive $1.5 Million Grant from the ALS Association to Help Fund Confirmatory Phase 2 Study of Neuraltus Pharmaceuticals' NP001 2Investigator to Receive $1.5 Million Grant from the ALS Association to Help Fund Confirmatory Phase 2 Study of Neuraltus Pharmaceuticals' NP001 3Investigator to Receive $1.5 Million Grant from the ALS Association to Help Fund Confirmatory Phase 2 Study of Neuraltus Pharmaceuticals' NP001 4Pistoia Alliance Launches Startup Challenge 2Pistoia Alliance Launches Startup Challenge 3
... Iowa Patricia Thiel of Iowa State University and the Ames ... of coasters to the middle and a trinket box to the ... lots of little things." So Thiel grabbed the smaller things and ... box. "Nature wants one big thing all together, like this." ...
... 2010 Cannabis Science, Inc. (OTC Bulletin Board: ... pharmaceutical cannabis products announced today that regardless of the ... electoral issues throughout the country, it is apparent that ... more important than ever, as the demand for the ...
... Inc. (NYSE Amex: PIP ), a biodefense ... announced today that the Company was awarded four separate ... Project, enacted as part of the Patient Protection and ... is a benefit targeted to small business therapeutic discovery ...
Cached Biology Technology:Iowa State, Ames Laboratory scientists advance the understanding of the big getting bigger 2Proposition 19 Decision Prompts Cannabis Science to Anticipate Increased Demand for its Pharmaceutical Products for Critical Ailments and Begin the Formal Application Process for FDA Clinical Trials Immediately 2Proposition 19 Decision Prompts Cannabis Science to Anticipate Increased Demand for its Pharmaceutical Products for Critical Ailments and Begin the Formal Application Process for FDA Clinical Trials Immediately 3PharmAthene Receives Four Therapeutic Discovery Project Grants Totaling Approximately $850,000 2PharmAthene Receives Four Therapeutic Discovery Project Grants Totaling Approximately $850,000 3
(Date:6/30/2015)... -- Genisphere announced Tom Bliss ... develop Genisphere,s therapeutics capabilities and portfolio. Mr. Bliss comes ... of the last 25 years in leadership positions at ... & Johnson. Tom started his career in Investment Banking, ... He graduated from Dartmouth College with a BA in ...
(Date:6/25/2015)... SALT LAKE CITY , June 25, 2015 /PRNewswire/ ... the first steps toward a healthier, happier life. That,s ... app is designed to do. The cutting-edge, portable health ... and offers real-life solutions to help improve your lifestyle ... Sellers Association awards dinner and gala Wednesday night, USANA,s ...
(Date:6/24/2015)... Calif. , June 24, 2015  Synaptics ... of human interface solutions, today announced that Sharp ... to provide secure authentication for its latest flagship ... reached more than 200 million shipments of its ... Sharp reinforces Synaptics, strength, scalability and leadership in ...
Breaking Biology News(10 mins):Genisphere Appoints New CEO, Thomas Bliss 2Genisphere Appoints New CEO, Thomas Bliss 3@USANAinc's Personalized Nutrition Program Wins Industry Innovation Award 2Synaptics Brings Natural ID Technology to Sharp's Newest Flagship Smartphone 2
... Lymphoma Protected by SPAK Silencing A group led ... of the protein SPAK may contribute to B-cell lymphoma development. ... issue of the American Journal of Pathology . ... system cancers. Epigenetic changes, such as DNA hypermethylation, may ...
... Consortium (PGSC), an international team of scientists from industry ... sequence of the potato genome with the help of ... horticulture in the College of Agriculture and Life Sciences ... potato variety that accelerated the development of a blueprint ...
... 2009Using clever chemistry, a Scripps Research team has pinpointed ... the progression of the devastating disease Friedreich,s ataxia in ... findings, developed in collaboration with scientists from Repligen Corporation, ... human clinical trials, which will be a welcome event ...
Cached Biology News:Tips from the American Journal of Pathology 2Tips from the American Journal of Pathology 3Tips from the American Journal of Pathology 4Tips from the American Journal of Pathology 5Draft potato genome based on unique potato variety 2Mechanism for potential Friedreich's ataxia drug uncovered 2Mechanism for potential Friedreich's ataxia drug uncovered 3
... tested through 63 ligand ... spanning a broad therapeutic ... includes many non human ... non-selective assays. Used ...
... The Genome Sequencer 20 System revolutionizes ... massively parallel fashion. The Genome Sequencer ... accessories Reagents and consumables for library ... for mapping and de novo assembly ...
Compound(s) tested through a broad panel of 38 ligand binding and enzyme assays targeting the Central Nervous System. Used to determine selectivity and potential CV/Renal liabilities of compounds....
... Human serum is obtained from normal human ... by a test for Human Immunodeficiency Virus ... Virus (Anti-HIV 1/2), Hepatitis C Virus (HCV), ... (HbsAg) and Non-reactive by a screening test ...
Biology Products: