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.
News & Events
- What are you waiting for? The FDA can review your data in ways you can’t
September 10, 2014
- Data Standardization Tools, Tips and Tricks for FDA’s e-Data / CDISC® SEND Submission
Replay of November 13, 2013 Webinar
- Uncovering Data Challenges as You Prepare for Submitting CDISC® SEND / e-Data to the FDA
Replay of October 16, 2013 Webinar
- Achieving Compliance with the FDA’s e-Data / CDISC® SEND Submission Initiative
Replay of October 3 Webinar
- FDA awards $20M IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats
Sept 26, 2013
- PointCross Receives ISO/IEC 27001:2005 Certification
- Preparing for Nonclinical eData Regulatory Submissions to the US FDA-"SEND" and Beyond
Replay of Sept 5 event
- PointCross Life Sciences Opens New Office in Silver Spring, MD for Data Standardization of Nonclinical Studies
July 9, 2013
- PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions
June 6, 2013
- PointCross Life Sciences named to Gartner’s 2013 Cool Vendor List for Life Sciences
May 17, 2013
- Joint EUROTOX poster between Roche and PointCross Life Sciences on the Use of Novel Computational Techniques to Identify Toxicity Signals in Drug
- Read how one Pharma client uses our technology for cross-study safety signal detection and analytics