PointCross Life Sciences has recently opened a new office in the Silver Spring, MD area where studies submitted by sponsors to the FDA in PDF and other formats will be standardized to fit into the Agency’s NIMS (Nonclinical Information Management System) environment. Increased access to such structured study data combined with computational review tools in NIMS are aligned with the Agency’s goals of integrating regulatory history into scientific information and advancing regulatory science research. New studies that require extensions to the NIMS data model to handle novel protocols, innovative studies and new study types will be modeled and provided to the FDA.
PointCross Life Sciences announces SaaS environment for FDA nonclinical study data reviewer analytics and submissions. This environment will support the preparation and review of study data sets prior to their submission to the FDA NIMS solution. These study data sets are not limited to the CDISC SEND 3.0 standard and they may include new domains and data types that sponsor companies wish to review using the same tool sets used by the FDA. (NIMS is the FDA’s implementation of the PointCross DSIMS – Drug Safety Information Management Suite)
Tags: Cool Vendors, Gartner, PointCross
The team at PointCross Life Sciences is very proud to have been selected as one out of five in the list of “Cool Vendors in Life Sciences, 2013” ¹ by Gartner, Inc. This report highlights select companies that offer novel tools to aggregate and deliver value from data for insight-driven performance improvements. We support the broad needs of translational informatics for the purposes of research, safety, and efficacy reviews. Click here to view the complete Cool Vendor List 2013 for Life Sciences report on the Gartner web site.
 Gartner “Cool Vendors in Life Sciences 2013” by Steven Lefebure, Dale Hagemeyer and Michael Shanler dated May 2, 2013.
The FDA will be mandating electronic submissions of study datasets in the CDISC SEND format. Pharmaceutical companies and CROs will need to transition to this format and ensure that they are SEND Ready. Several companies that we have talked to and are working with are well on their way to achieving this goal.
Some companies may choose to meet this regulatory requirement o a per study basis. In other words, due to their low volume of submissions to the FDA, they may choose to have a company take their nonclinical study data in an electronic format, final study data report or both and produce the e-Data submission file for them. Or a company may plan to implement a solution on the Cloud or behind their fire wall, but want to begin sending e-Data submissions to the FDA now and not wait till a more permanent solution is in place. PointCross Life Sciences is offering the SEND-as-a-Service solution to meet these needs.
To find out more information on our service and the pricing model, contact us at getSENDReady@pointcross.com.
Dr. Suresh Madhavan, CEO & CTO of PointCross and Dr. Jon Kimball, PointCross Advisor will be presenting at the SPE Digital Energy Conference on Upstream E&P and Drilling Safety Optimization – Lessons from the BioPharma R&D Industry. This session is scheduled at 3:30 PM on Wednesday, March 6, 2013.
The 2nd annual PointCross Life Sciences User Meeting was held on Nov 14-15, 2012 in Silver Spring, MD. The 2 days were packed with content presented by PointCross Life Sciences architects, industry consultants, and several users of the technology solutions PointCross Life Sciences provides. The 1st day of the meeting was mostly focused on CDISC SEND and it’s impact on nonclinical research and the submissions to the FDA. The 2nd day was more focused on translational analytics and clinical research solutions and roadmap.
As a way to continue the collaboration amongst the attendees of the User Meeting (and others interested in PointCross Life Sciences solutions as well as SEND topics), we would like to use this blog. Please feel free to post your comments, questions or discussion topics and let’s keep the communications from the User Meeting flowing!