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 non-clinical phase of the R&D lifecycle and it creates an instantly searchable resource of all non-clinical 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 non-clinical 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 behaviour 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” he further added.
Integrating in vitro assays with non-clinical 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. SDIS is immediately available and can be deployed behind the company firewall, or accessed from a secure PointCross hosted environment.
PointCross is a global provider of advanced strategic business solutions to knowledge-rich markets, including the Pharmaceutical, Biotech and Upstream Oil & Gas industries. It is headquartered in the California Bay Area with offices in Houston, Texas, Paris, France and Bangalore, India. We have a network of data integration and scientific consulting partners, and our solutions are used by BioPharma companies, as well as by the FDA.