Integrated Repository of Nonclinical Studies: A Case Study for a Centralized, Searchable Registry of all Nonclinical Studies for Drug Safety and Toxicology Research
Case Study: Integrated Repository of Nonclinical Studies
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PointCross Testing
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...
Clinical Data Repository for SDTM data fills an urgent gap
Kavan Palangappa2023-06-27T10:46:41+00:00CIMS™, the PointCross Life Science built Repository for Clinical SDTM Data is now available to Pharma sponsors with compliant standardized NDA submissions to FDA guidance. Silver Spring, MD, March 14, 2016 PointCross Life Sciences today announced its formal release of CIMS™, a Hadoop (HDFS) based extensible repository. CIMS has extensive workflows and validations systems built-in for...
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....
PointCross Life Sciences and CAC EXICARE forge strategic implementation plan
Kavan Palangappa2023-05-03T09:52:56+00:00For 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, CA, August 24th, 2015 — PointCross Life Sciences and...
PointCross announces SaaS offerings on the cloud to span the entire lifecycle of eData submissions to FDA
Kavan Palangappa2023-05-03T09:52:04+00:00Nonclinical 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 Spring, MD, June 8, 2015 – Today PointCross announced two new SaaS offerings to complement its DSIMS-as-a-Service solution. These new...