Study Data Integration & Search - SDIS

Close[X]
Biopharma companies need new ways of generating insights from the vast amounts of R&D data they generate to address drug safety concerns, shrinking pipelines and comparative efficacy of their drug candidates. This is particularly important in the nonclinical phase of development prior to expensive and potentially risky clinical trials.

PointCross’ Study Data Integration and Search (SDIS) solution addresses this unmet industry need by providing a one-stop “Data-to-Insights” environment for nonclinical scientists to evaluate safety and efficacy indicators and biomarkers across normalized study data spanning internal and external sources, and global research sites. With SDIS, scientists can rapidly search for trends, weak signals, and cross-study correlations across the cumulative nonclinical knowledge base to make better informed pipeline and project-specific decisions.

When used in cross-company collaborations, SDIS creates an instantly searchable, secure library of shared nonclinical data for Biopharma companies and collaborative consortia like the Innovative Medicines Initiative (IMI) in Europe and C-PATH's Predictive Safety Testing Consortium. Blind search workflows allow relevant information to be exclusively shared with potential licensing or development partners.

SDIS has been proven across thousands of studies from both electronic data collection systems as well as PDF/paper reports at major Biopharma companies. The accompanying ToxVision viewer is used by the FDA to review and analyze regulatory data submissions in SEND format.

Benefits:

  • Accelerate programs by quickly discovering elusive safety and efficacy trends across all nonclinical data
  • Increase research productivity by accelerating previously manual and time-consuming reviews of study data and reports
  • Improve regulatory communications by catching key translational issues early, and responding rapidly to agency requests
  • Capture and reuse institutional memory across studies, projects and drug candidates
  • Drive operational excellence by streamlining the exchange of nonclinical study data with regulators, CROs and partners

Technology

SDIS uses ontologies, automated metadata extraction and harmonization techniques to normalize and integrate data across internal and CRO systems. Mathematical indexing of structured data is combined with specialized text and parametric meta-data extraction, indexing, meta-analysis tools and search technology to deliver a new capability to toxicologists, pathologists and to other scientists and safety personnel so they can gain better scientific insights across studies.

SDIS is delivered with an extensible universal data model and ontologies across an array of nonclinical study and assay types. Our Semantic Data Exchanger allows rapid and effective interchange of nonclinical data among companies and systems using standardized formats including SEND, SD (Structure-Data), ToxML, and other vendor-neutral schema including XML, CSV and SAS transport (.xpt) file formats. Information visualization and analytics are enabled through the embedded ToxVision viewer.

SDIS is immediately available either as an enterprise deployment or as a secure hosted offering. PointCross provides all necessary installation, configuration and data conversion services to support SDIS deployments.

News & Events

© 2011 PointCross, Inc.