Xbiom– A Workbench for Biomarker & Translational Research
The paper presents query masks for stratifying cohorts and search analytics on clinical and biomarker data as available on the Xbiom solution
PointCross Testing
Benchmark Your SEND Readiness Whitepapers
Kavan Palangappa2023-05-19T13:29:30+00:00Benchmark Your SEND Readiness
Synthetic Dataset
Kavan Palangappa2023-03-30T12:33:12+00:00Synthetic Dataset for Public Use (PC201708)
SEND ASSURE™ Whitepaper
Kavan Palangappa2023-05-15T07:35:48+00:00Assuring your SEND Datasets are Consistent with your Study Report...
Drug Safety Information Management
Kavan Palangappa2023-08-08T12:26:02+00:00Specify, Validate, Package and Review SEND data for FDA Submissions...
Data Standardization Services
Kavan Palangappa2021-06-16T14:40:23+00:00Receive a SEND package guaranteed to load into the FDA's Nonclinical Portal...
Data Consistency and Quality Issues in SEND Datasets
Kavan Palangappa2023-08-09T09:26:57+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...
Importance of Data Consistency and Quality in SEND Submissions
Kavan Palangappa2023-08-09T06:09:04+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...
FDA’s Binding Guidance on Electronic Study Data Submissions
Kavan Palangappa2023-08-09T06:20:02+00:00On December 18th 2014, the FDA issued binding guidance regarding electronic submissions of nonclinical study data. This means that beginning in 2017, any organization making IND, NDA or BLA submissions...
Semantic Data Exchange for Pharma R&D
Kavan Palangappa2021-06-16T14:42:44+00:00Semantic Data Exchange Facilities to enable flexible support for data standards and cross-study meta analysis in the Pharmaceutical Industry...