PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management Suite
FOSTER CITY, CA, March 12, 2012 PRNewswire The FDA has announced its intention to require Pharma companies to include nonclinical study data in standardized electronic formats as part of regulatory IND, NDA and BLA submissions. This directive is intended to help FDA reviewers better predict safety impacts of drugs in humans, and to improve regulatory...
Enhancing Drug Development with Tox Vision ++
PointCross Life Scienecs ToxVision++ is a viewer that extends the reach and power of the original ToxVision viewer to provide new ways to visualize, compare, and evaluate nonclinical study data in a single, standards-based environment. In a single tool, ToxVIsion++ reseolves how GLP data is received, stored, displayed, charted, extracted, reported, and how basic...
Guarding Your Drug Safety Blind Spots
Hosted Webinar: DSEC Panel Discussion: Search, Analytics and SEND: Guarding Your Drug Safety Blind Spots Sponsored by PointCross Life Sciences The FDA has announced its intent to mandate nonclinical data submissions in standardized formats like SEND. Consequently, Agency reviewers expect to be spending more time on data analysis and detection of potential safety signals across studies....
Enhancing Drug Safety with Tox Vision
ToxVision is the first viewer designed to automate the visualizing and normalizing of study data; ensuring the safety of drugs submitted for regulatory approval. Developed by PointCross Life Sciences, in collaboration with the FDA, Toxvision reads SEND data, making it easier for you to spot important signals and trends among a huge volume of...
Study Data Integration & Search (SDIS™) Demo
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 to Provide the FDA With Nonclinical Study Data Software and Services
Press Releases PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services FOSTER CITY, Calif., Oct. 3, 2011 PRNewswire PointCross Life Sciences, Inc. has announced that it has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the U.S. Food and Drug Administration to provide an integrated off-the-shelf software environment comprising of...
Streamline Study Data Integration with SD
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.