Nonclinical Study Data Specification (NSDS) for definition of a study before it begins, and ToxVision-as-a-software-Service to review studies after they are completed using the same visualization and analysis tools as in FDA’s NIMS are now available as a software subscription.
Silver Spring, MD, June 8, 2015 – Today PointCross announced two new SaaS offerings to complement its DSIMS-as-a-Service solution. These new offerings complete the entire data supply chain from CRO to Pharma/Biotech to FDA. The FDA’s binding guidance released December 2014 requires studies to be CDISC SEND compliant by late 2017. NSDS is a web-based software with tools for Pharma/Biotech companies and their CROs to jointly define and specify the data and models of nonclinical studies before they are started.
ToxVision-as-a-software-Service provides Pharma/Biotech companies with the same tools the FDA uses to conduct their regulatory reviews on SEND datasets. The existing DSIMS-as-a-Service is available to Pharma/Biotech companies and CROs to package study data in SEND using the data specifications established in NSDS. DSIMS is a private hosted software service. NSDS and ToxVision are Single Instance Multi-tenant cloud-hosted software services. Kristi Johnson, who heads Data Standardization at PointCross, said “This is important news for small and large BioPharma companies who need to be compliant. They now have a cost effective and efficient process that makes the data supply chain predictable and risk free for both Pharma companies and CROs or labs.”
About PointCross Life Sciences
PointCross Life Sciences provides the life sciences industry with data management, analytics and visualization solutions that reduce risks, improve data quality, shorten time to market, and generate better insights from R&D and regulatory data. Our SEND related software includes NSDS to define the study, DSIMS to prepare, package and review the study, and ToxVision to review with the same tools in FDA’s NIMS. We are a registered CDISC solution provider and collaborate with consortia like PhUSE. PointCross was recognized in 2013 as one of Gartner’s Cool Vendors in Life Sciences.