How to Integrate Clinical, Biomarker, and Other Disparate Data Sources
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
Read more...
PointCross Testing
SEND ASSURE™ Whitepaper
Kavan Palangappa2023-05-15T07:35:48+00:00Assuring your SEND Datasets are Consistent with your Study Report...
DSIMS™ Software-as-a-Service
Kavan Palangappa2021-06-16T14:39:55+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 Palangappa2023-03-29T11:53:59+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 Palangappa2021-08-05T14:14:08+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 Palangappa2021-06-16T14:42:26+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...
Steps to Comply with the FDA’s Binding Guidance on Electronic Study Data Submissions
Kavan Palangappa2021-06-16T14:42:36+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 Palangappa2023-05-03T10:01:55+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....