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. CIMS has extensive workflows and validations systems built-in for specifying clinical trial data models, receiving interim trial updates, planning, and packaging submissions for eCTD submission in M5 folders. CIMS exploits the standardized data exchange formats of CDISC SDTM with its semantic technology and its ontology engine to ensure that the eCRF and ADaM data is easily accessible to SAS or other statistics platforms for safety and efficacy analysis. A validated implementation of CIMS has been operational since mid 2014.
“Clinical data have required trial specific data bases and customized analytics. CDISC’s SDTM data exchange standards have dramatically transformed this for the better. The FDA’s mandate for SDTM formatted clinical data means that patient data can be captured and stored for easy access in a data base agnostic manner using NoSQL technology which we used for nonclinical study data.” said Dr. Suresh Madhavan, CEO of PointCross Life Sciences.
About PointCross Life Sciences
PointCross provides the Life Sciences industry with products for “Big Data” analytics of nonclinical, clinical and omics metadata from bio-samples, repositories, and visualization. Our offerings provide scientific insights through signal and pattern analysis to reduce risks, improve data quality, accelerate time to market, and enable better insights across R&D and regulatory data.
The FDA uses PointCross technologies for their SEND viewing, signal detection, validation and repository needs for safety review of nonclinical study data. To learn more, visit www.pointcrosslifesciences.com.
