PointCross announces the release of its Study Data Integration and Search (SDIS) technology and associated services to the BioPharma industry for private use with legacy and current studies. 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 collaborative consortia like the C-PATH Predictive Safety Testing Consortium and the Innovative Medicines Initiative (IMI) in Europe.
BioPharma companies and regulatory agencies have growing concerns regarding biomarkers and trends that point to safety and efficacy indications which are hidden in the massive amounts of disparate study data they possess. There has never been a way for scientists or biostatisticians to rapidly search for trends, weak signals and cross-study correlations. Finding these markers in nonclinical data can result in huge savings, operational efficiencies, and better portfolio decisions that improve product pipelines and reduce late stage safety related attrition. “Imagine discovering two, 20 year old studies that exhibit similar behavior in certain sets of markers to a recent study and then discovering that the earlier drugs failed in the clinic due to toxicity,” said Dr. Shree Nath, VP, Pharmaceuticals & Life Sciences, PointCross, Inc. “That would be like finding a gold mine while digging right in your own backyard using a new set of tools.”
Integrating in vitro assays with nonclinical in vivo studies that follow disparate protocols is an industry first. SDIS uses ontologies, semantic data exchange and harmonization techniques to integrate data across internal and CRO systems. This is combined with specialized parametric meta-data extraction, indexing and search technology to deliver new scientific insights across studies. The technology has been proven with many thousands of studies at one of the Top 10 Big Pharma companies. Deployments are supported with a proven process to regenerate tabulated data and text from legacy paper and PDF reports previously submitted to regulatory agencies into usable data.
SDIS can be used for contributing study data in standardized formats to alliance partners and collaborative safety data sharing consortia such as IMI. In-house processes are provided for the selection of study data to be shared from the internal inventory using simple search and redaction facilities to preserve confidentiality.
Source : PointCross