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 for the Exchange of Nonclinical Data. This will enable reviewers to analyze all the studies across species in a submission, and to detect weak or important toxicity signals in the data. To help Biopharma companies and their CROs prepare for such regulatory analytics, PointCross Life Sciences announces the immediate availability of its SENDBox™ and SEND-as-a-Service offerings.
Biopharma companies and CROs can use the SENDBox to assemble data from GLP validated data collection systems, transform them into SEND, and view them before submission. SENDBox is offered with tools to meet Computer Systems Validation requirements. It is available as an Enterprise solution behind company firewalls or as a Cloud-hosted service. SENDBox is based on and compatible with DSIMS™, the engine behind the FDA’s SEND-compliant Nonclinical Information Management System (NIMS). NIMS helps the Agency to better evaluate the safety impact of drugs and improve reviewer efficiency.
SEND-as-a-Service is a Cloud-hosted offering intended for sponsors and CROs who simply wish to outsource the packaging of their disparate datasets, current or past, into SEND. This service converts their data into SEND ready packages for submission or for analyzing their data in the same way as reviewers.
According to Dr. Shree Nath, VP of PointCross Life Sciences, “The Biopharma industry is moving quickly to become ready for the FDA’s upcoming e-data submission directive. Three top Sponsor companies have selected PointCross to deliver their SEND implementations after a careful evaluation of other providers. Clients now have the flexibility of deploying the SENDBox solution and assembling SEND datasets themselves, or have our experts do it for them through SEND-as-a-Service. These new offerings complement our proven DSIMS™ solution and provide large, mid-size and small Biopharma companies with options that best fit with their business needs.”