ESAC, Inc. has been awarded a multi-year contract to support the FDA Individual Case Safety Report (ICSR) Standard

September 30, 2017

The HL7 Individual Case Safety Report (ICSR) standard is the data standard which permits the capture of adverse events data in a format that FDA can process, review, and archive. ESAC was contracted to work with the various FDA centers to include the additional data elements required for FDA adverse event reporting. This work effort includes:

  • Developing, updating, and maintaining an open source Schematron document based on the business rules and data relationships for FDA regulated adverse event data
  • Develop HL7 ICSR implementation guide to be utilized by industry and ICSR software developers to generate valid regulatory submissions for processing, reviewing, and archiving by FDA

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ESAC's technical savvy and personable staff provides tremendous value to projects involving multi-center coordination and high dimensional data management. They merge a fundamental understanding of biology with expertise in data quality control and data security. Integrating all of these factors is key to delivering a secure and fast data portal for the scientific community.

Program Manager
NCI

We are quite impressed with not only by the technical skills provided by ESAC's software engineers but also by the depth and breadth of their subject matter experts who have provided guidance on standards and interoperability, quality assurance, and project management issues.

COTR
HHS/ONC

ESAC significantly improved the quality of bioinformatics applications of the NCI CBIIT program using industry best practices to ensure systems were validated both functionally and scientifically for use by the community.

Program Manager
NCI

ESAC continues to be an exceptional collaborator providing on-site contractors with both the expertise for building new tools and data integration platforms, and the subject matter expertise in the biosciences needed to manage projects and provide significant added value beyond the technology development.

Director
Innovation Center for Biomedical Informatics at Georgetown University Medical Center

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