PointCross announces SaaS offerings on the cloud to span the entire lifecycle of eData submissions to FDA
Nonclinical Study Data Specification(NSDS) for the 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.”
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