PointCross Life Sciences offers technologies and services for the access, exchange, analytics, regulatory review, and visualization of data from nonclinical studies and clinical trials conducted by BioPharma organizations.
Global pharmaceutical companies use SDIS™, our cross-study analytics solution, for research and development purposes. DSIMS™ is a solution for reviewing nonclinical studies and for packaging them to CDISC SEND standards.
DSIMS™ is implemented at the FDA as their NIMS environment since 2012 for accepting NDA and IND submissions for regulatory review. We provide data standardization services to the FDA for sponsor submissions. These standardized studies are loaded into NIMS for viewing, analysis, and reporting by regulatory reviewers. This service is offered to all of our commercial clients from our global service centers.
We are extending our products to provide translational analytics across nonclinical and clinical data and metadata using adverse events, safety and efficacy signals, and from genomic and NGS data in internal and external data registries. We were listed on Gartner’s 2013 List of Cool Vendors in the Life Sciences informatics space.
We apply a stack of technologies appropriate for the type of data and business problem. These include next generation highly scalable petabyte sized data stores based on Hadoop®; and advanced analytics, visualization and workflows built on our Orchestra® based ontology technology and semantic data exchangers. Our solutions are available on-premise, on our Private Cloud, as well as on our Single Instance Multi-Tenant (SIMT) Cloud offering tuned for short-term access or for small biotech companies.
- Webinar: Steps to Comply with FDA Guidance
January 22, 2015 with repeat sessions also in Japanese, German and French
- SOT 54th Annual Meeting and ToxExpo
San Diego, California, March 22-26, 2015
- PhUSE Computational Science Symposium
Silver Spring, Maryland, March 15 -17, 2015
- Webinar : Learn about ambiguities in the SEND standard that need to be resolved for FDA Submission and Review Purposes
Replay of December 11th, 2014
- ACT 35th Annual Meeting
Attend the PointCross Hosted Program “Submitting Standardized SEND Data to the FDA: Data Fitment and Review Considerations”
November 9th, 2014