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...
Xbiom™: Precision Medicine Biomarker Research
There is a perfect storm brewing where advances in genomic screening, identifying molecular biomarkers and precisely targeted medicines and diagnostics, smart monitoring of patient vitals and physiology using devices such as smart phones and...
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...
