Date: March 22–26, 2026Location: San Diego, California PointCross attended the Society of Toxicology (SOT) 65th Annual Meeting and ToxExpo, held March 22–26, 2026, in San Diego, CA. The event brought together leading toxicologists, researchers, regulators, and industry professionals to share the latest scientific discoveries, technologies, and regulatory advancements in toxicology. At Booth #2107, the PointCross team...
Xbiom™ Platform Introduces AI-Enabled Automated Workflow that Eliminates Redundant Processes, Reduces Costs by 50%, and Accelerates IND-Enabling Regulatory Submission Readiness by 2-4 Weeks. Foster City, CA, December 18, 2025 PointCross today announced general availability of an AI augmented transformative single-track process for nonclinical data management. The innovation enables simultaneous generation of submission-ready Study Reports and...
PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing demand from sponsor Clinical...
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 ( Technical Rejection Criteria for Study Data) The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th,...
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 ( Technical Rejection Criteria for Study Data) The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th,...
XYBION AND POINTCROSS ESTABLISH A STRATEGIC PARTNERSHIP TO DELIVER SEND SERVICES TO ASSURE FDA REVIEW READY SUBMISSIONS March 11, 2016: PointCross Life Sciences and Xybion announced today a strategic partnership to provide the Biopharma industry with a complete suite of data management, standards governance, data quality assurance and regulatory review solutions to comply with the FDA’s...
PointCross Life Sciences and CAC EXICARE forge strategic implementation plan For pharma and biotech companies in Japan, this collaboration will ease the implementation of CDISC standards for electronic regulatory submissions which are a requirement by both the US FDA and Japanese PMDA CAC EXICARE’s Location in Tokyo Japan and PointCross Life Sciences’s Location in Foster City,...
FOSTER CITY, CA, June 6, 2013 PRNewswire PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDA’s NIMS (Nonclinical Information Management System) solution. These study data sets are not limited to the...
PointCross Life Sciences Named to Gartner’s Cool Vendor 2013 List for Life Sciences FOSTER CITY, CA, May 15, 2013 PointCross Life Sciences announced today that it has been included in the list of “Cool Vendors in Life Sciences, 2013” ¹ by Gartner, Inc. PointCross Life Sciences is a leading provider of solutions designed to unleash the...