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...
Semantic Data Exchange Facilities to enable flexible support for data standards and cross-study meta analysis in the Pharmaceutical Industry...
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,...
Foster City, CA, April 20, 2015 /PRNewswire/ — PointCross Life Sciences today announced a strategic partnership with InterpretOmics Pvt. Ltd. to provide an integrated Big Data and globally accessible environment for genomic interpretation and analysis of all biomarkers collected in the context of clinical trials and nonclinical studies. This platform will serve the needs...
PointCross Life Sciences Named to Gartner’s Cool Vendor 2013 List for Life Sciences FOSTER CITY, CA, May 15, 2013 PointCross Life Sciences announced today that it has been included in the list of “Cool Vendors in Life Sciences, 2013†¹ by Gartner, Inc. PointCross Life Sciences is a leading provider of solutions designed to unleash the...
PointCross Life Sciences' SEND solutions are designed to help the industry become SEND Ready over the next 18-24 months and support their future research needs.
Watch the replay of this webinar held on June 27: What does SEND Readiness mean for your company The FDA will soon require drug companies to transmit their nonclinical data submissions in standardized electronic formats like SEND. This will fundamentally impact workflows and data management within drug companies and CROs, and will require nonclinical toxicologists to...
PointCross Life Sciences SDIS is the first solution of its kind that closes a major gap in the nonclinical phase of the R&D lifecycle. SDIS creates an instantly searchable resource of all nonclinical study and assay data for BioPharma companies and regulatory agencies.
PointCross Life Sciences Study Data Integration and Search solution for the Biotech and Pharmaceutical industry provides a one-stop "Data-to-Insights" environment for nonclinical scientists to evaluate safety and efficacy indicators and biomarkers across normalized study data spanning internal and external sources, and global research sites.