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

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.


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 analytics, data store and translational informatics solutions and Data Standardization Services designed for large, complex, 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 the FDA and several global Biopharma companies. The FDA's NIMS solution is based on the PointCross DSIMS platform. PointCross Life Sciences is a wholly owned subsidiary of PointCross, Inc.

Dr. Shree Nath, Vice President
PointCross Life Sciences, Inc.
1291 E. Hillsdale Blvd., Suite 304
Foster City, CA 94404
1-866-468-1900 or

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

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:
(Date:6/27/2016)... , June 27, 2016  Liquid Biotech ... announced the funding of a Sponsored Research Agreement ... circulating tumor cells (CTCs) from cancer patients.  The ... in CTC levels correlate with clinical outcomes in ... These data will then be employed to support ...
(Date:6/24/2016)... , ... June 24, 2016 , ... While the majority ... as the Cary 5000 and the 6000i models are higher end machines that use ... height of the spectrophotometer’s light beam from the bottom of the cuvette holder. ...
(Date:6/23/2016)... June 23, 2016   Boston Biomedical , ... compounds designed to target cancer stemness pathways, announced ... granted Orphan Drug Designation from the U.S. Food ... gastric cancer, including gastroesophageal junction (GEJ) cancer. Napabucasin ... to inhibit cancer stemness pathways by targeting STAT3, ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm ... Mold) microbial test has received AOAC Research Institute approval 061601. , “This is ... last year,” stated Bob Salter, Vice President of Regulatory and Industrial Affairs. “The ...
Breaking Biology Technology:
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
(Date:3/31/2016)... , March 31, 2016 ... ) ("LegacyXChange" or the "Company") LegacyXChange is ... users of its soon to be launched online site ... ) will also provide potential shareholders ... of DNA technology to an industry that is notorious ...
(Date:3/22/2016)... , March 22, 2016 ... report "Electronic Sensors Market for Consumer Industry by Type ... Others), Application (Communication & IT, Entertainment, Home ... Global Forecast to 2022", published by MarketsandMarkets, ... expected to reach USD 26.76 Billion by ...
Breaking Biology News(10 mins):