Integrating Clinical, Biomarker & Disparate Data
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
PointCross Testing
Introducing PointCross Desktop Validator
Kavan Palangappa2024-06-14T06:11:39+00:00July 20 2022 - 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...
SEND ASSURE™ Whitepaper
Kavan Palangappa2024-06-14T06:11:39+00:00Assuring your SEND Datasets are Consistent with your Study Report...
Data Standardization Services
Kavan Palangappa2024-06-14T06:11:41+00:00Receive a SEND package guaranteed to load into the FDA's Nonclinical Portal...
Data Consistency and Quality Issues in SEND Datasets
Kavan Palangappa2024-06-14T06:11:43+00:00PointCross has reviewed numerous SEND datasets prepared for test submissions to the FDA and has worked with the FDA on their KickStart program to ensure that received datasets are suitable for pharm/tox review...
PointCross Life Sciences and Xybion forge strategic partnership to deliver SEND services to assure FDA review ready submissions
Kavan Palangappa2024-06-14T06:11:44+00:00XYBION 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...
Importance of Data Consistency and Quality in SEND Submissions
Kavan Palangappa2024-06-14T06:11:44+00:00With the recent release of the FDA’s binding guidance for electronic submission of nonclinical data, sponsor submissions will be required to include electronic datasets in SEND format in addition to the study report...
Semantic Data Exchange for Pharma R&D
Kavan Palangappa2025-07-14T07:28:59+00:00Semantic Data Exchange Facilities to enable flexible support for data standards and cross-study meta analysis in the Pharmaceutical Industry...
PointCross & CAC EXICARE Partner for CDISC Implementation
Kavan Palangappa2024-06-14T06:11:47+00:00PointCross 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,...
PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions
Kavan Palangappa2026-05-20T10:18:36+00:00FOSTER 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...