PointCross announces SEND ASSURE for Data Consistency in Submissions to the FDA SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions Silver Spring, MD, March 9, 2015/ PRNewswire PointCross Life Sciences today announced the launch of its SEND-ASSURE audit solution to help pharmaceutical companies avoid the consequences of submitting standardized nonclinical data that is...
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...
Preparing for Nonclinical eData Regulatory Submissions to the US FDA-“SEND” and Beyond Presenters: Shree Nath, PhD, Vice President, PointCross Life Sciences Timothy J. Kropp, PhD, Team Leader, Tools Technology and Innovation Team, US Food and Drug Administration The recording of this webinar is no longer available from the American College of Toxicology but the presentation slides are available...
FOSTER CITY, CA, June 6, 2013 PRNewswire PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDA’s NIMS (Nonclinical Information Management System) solution. These study data sets are not limited to the...
PointCross Life Sciences Named to Gartner’s Cool Vendor 2013 List for Life Sciences FOSTER CITY, CA, May 15, 2013 PointCross Life Sciences announced today that it has been included in the list of “Cool Vendors in Life Sciences, 2013” ¹ by Gartner, Inc. PointCross Life Sciences is a leading provider of solutions designed to unleash the...
PointCross Life Sciences' SEND solutions are designed to help the industry become SEND Ready over the next 18-24 months and support their future research needs.
Press Releases PointCross Life Sciences’ SEND Box and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s Upcoming e-Data Submission Mandate FOSTER CITY, CA, 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...
PointCross Life Sciences' DSIMS is a suite of software applications, repositories, tools, viewers, customizable workflows and stage-gated processes, and enabling technologies for accessing and managing nonclinical study data for researchers, toxicologists, reviewers, and regulatory reporting staff. DSIMS has a hub-and-spoke architecture for safety data. The hub is the NSDR repository, which has, at its...
Watch the replay of this webinar held on June 27: What does SEND Readiness mean for your company The FDA will soon require drug companies to transmit their nonclinical data submissions in standardized electronic formats like SEND. This will fundamentally impact workflows and data management within drug companies and CROs, and will require nonclinical toxicologists to...
FOSTER CITY, CA, March 12, 2012 PRNewswire The FDA has announced its intention to require Pharma companies to include nonclinical study data in standardized electronic formats as part of regulatory IND, NDA and BLA submissions. This directive is intended to help FDA reviewers better predict safety impacts of drugs in humans, and to improve regulatory...