FOSTER CITY, Calif., Feb. 15, 2017 (GLOBE NEWSWIRE) — PointCross Life Sciences came out of stealth mode with its Xbiom™ Insights solution for Clinical Biomarker research. With two clients deployed, PointCross is now acquiring new pharma and biotechnology companies who are pursuing precisely targeted therapies in oncology, central nervous system, and cardiovascular. Having proven...
July 20 2022 - PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing...
Assuring your SEND Datasets are Consistent with your Study Report...
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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...