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...
Integrated Repository of Nonclinical Studies: A Case Study for a Centralized, Searchable Registry of all Nonclinical Studies for Drug Safety and Toxicology Research In this case study we describe how a major Biopharma ranked in the top three, uses Xbiom Nonclinical as a centralized, shared searchable repository of all ongoing, current and legacy studies across...
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...
Clinical Data Repository for SDTM data fills an urgent gap CIMS™, 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....
XYBION 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...
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...
On 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 Facilities to enable flexible support for data standards and cross-study meta analysis in the Pharmaceutical Industry...
For 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 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,...