Integrating Clinical, Biomarker & Disparate Data
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
Introducing PointCross Desktop Validator
July 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...
SEND ASSURE™ Whitepaper
Assuring your SEND Datasets are Consistent with your Study Report...
Data Standardization Services
Receive a SEND package guaranteed to load into the FDA's Nonclinical Portal...
Data Consistency and Quality Issues in SEND Datasets
PointCross 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...
Importance of Data Consistency and Quality in SEND Submissions
With 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
Semantic Data Exchange Facilities to enable flexible support for data standards and cross-study meta analysis in the Pharmaceutical Industry...
