PointCross Life Sciences today announced the launch of its SEND-ASSURE audit solution to help pharmaceutical companies avoid the consequences of submitting standardized nonclinical data that is inconsistent with their study reports. CDISC SEND standardized data is required for NDA, BLA and IND submissions to the FDA starting in 2016. Data consistency and quality issues in standardized data will cause delays in regulatory review by the FDA, or even result in a refusal to file. This in turn can delay time-to-market of important drug products.
SEND-ASSURE is offered directly from PointCross Life Sciences initially and soon with a major Cloud partner. Sponsors and their CROs are also provided views of their SEND data using the same PointCross DSIMS™ product deployed as NIMS at the FDA.
Highlighting the importance of this new offering, Kristi Johnson, SEND Data Services Manager, PointCross Life Sciences said, “If you are a Pharmaceutical company, you really cannot afford delays in the regulatory review process because of avoidable issues with your SEND data. Our experts who support the FDA’s JumpStart Nonclinical Service are experienced in identifying these issues from actual submissions. By offering this solution to the industry, we hope that submitted data will achieve a high degree of consistency to improve the review process“.