1. Use our software to specify and interact with your CROs, merge non-clinical study datasets, package into CDISC-SEND and ensure reviewability before submission to the FDA. OR
2. Provide PointCross with your disparate data sources and have us deliver quality assured and submittable SEND datasets as a service. OR
3. Provide us with the SEND study dataset generated by your CROs and have us check its reviewability using our SEND-ASSURE service.
Xbiom™Regulatory - Nonclinical
Drug Safety Information Management Suite (DSIMS)
DSIMS includes NSDS for specifying the SEND or LIMS data that must be provided for merging and packaging into a single SEND study. It includes the capability of specifying the SEND related Trial Design, applicable domains and the format for subject names.
DSIMS includes SWP – Study Workflow Process for packaging and merging disparate data to generate validated SEND datasets.
DSIMS also includes the regulatory review tool, ToxVision, which was developed under a CRADA with FDA.
Gartner, Cool Vendors in Life Sciences, 2013, Steven Lefebure, Dale Hagemeyer, Michael Shanler, 02 May 2013.The Gartner Cool Vendor Logo is a trademark and service mark of Gartner, Inc., and/or its affiliates, and is used herein with permission. All rights reserved. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner's research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.
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