Data Standardization Services
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PointCross Testing
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...
PointCross Life Sciences and Xybion forge strategic partnership to deliver SEND services to assure FDA review ready submissions
Kavan Palangappa2023-08-08T12:41:33+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 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...
PointCross Life Sciences and Smithers Avanza forge strategic partnership for SEND solutions
Kavan Palangappa2023-08-08T13:10:07+00:00For biopharma companies, this collaboration will streamline the flow of high quality CDISC SEND standardized data for regulatory submissions required by the FDA and to serve sponsor R&D needs Silver Spring, MD, November 9th, 2015 PointCross Life Sciences and Smithers Avanza announced today that they have entered into a partnership to provide SEND solutions to their Toxicology Services clients....
PointCross & CAC EXICARE Partner for CDISC Implementation
Kavan Palangappa2023-08-09T10:00:32+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 offers FDA eData SaaS lifecycle on cloud
Kavan Palangappa2023-08-09T09:52:48+00:00PointCross announces SaaS offerings on the cloud to span the entire lifecycle of eData submissions to FDA Nonclinical Study Data Specification(NSDS) for the definition of a study before it begins, and ToxVision-as-a-software-Service to review studies after they are completed using the same visualization and analysis tools as in FDA’s NIMS are now available as a software subscription. Silver...
NIMS v2.5 for SEND released to FDA, Industry access
Kavan Palangappa2023-08-09T09:48:53+00:00NIMS Version 2.5 for SEND released to the FDA, Now Available for Industry NIMS enables faster, deeper and more insightful regulatory review of nonclinical study data for safety signal detection and analysis Silver Spring, MD, March 12, 2015/ PRNewswire PointCross Life Sciences today announced that the FDA has accepted NIMS version 2.5 for operational use to review...