Implementing Entimo Solutions
The following entimICE-based products are currently offered by entimo in the clinical area - all integrated into one seamless process from raw data to submission:
Data Analysis and Reporting Environment is a statistical computing environment that facilitates statistical programming and data management in a fully controlled and traceable manner. The solution integrates available programming data sources and tools in a central repository and provides for audit trails, versioning, date stamps and electronic signatures along the entire study life-cycle. Among other distinguishing features, entimICE® DARE tracks dependencies between objects involved in the analysis process, reports outdated ones and supports workflow definition. This controlled approach provides a high level of data transparency and clarity.
Entimo’s data mapping environment facilitates the transformation of datasets to arbitrary target structures including CDISC SDTM. The mapping tool provides a comfortable graphical interface to create mapping definitions. Thus minimum programming skills are required. A broad number of built-in standard conversion functions are available in the tool and can be easily enhanced with specific user-defined actions. Mappings are defined based on metadata which can be easily imported or derived from available datasets. Therefore, you can begin with the definition of mappings even before real datasets are available. Prior to mapping creation, you can analyze datasets with a comprehensive profiling tool.
Entimo’s SDTM and ADaM Checkers are validated SAS® macro solutions which verify compliance of clinical data with CDISC SDTM and ADaM. These tools inspect structure and controlled terminology, run officially published and additional checks and provide detailed reports including result statistics. Driven by metadata and configurable, they easily support standard and custom domains as well as integration of user defined checks. Datasets to be checked are simply specified as program parameters. Once defined, the parameter sets can be used for repeated runs with no additional effort. Detailed test results are presented in different formats for effortless analysis.
In Entimo’s Integrated Clinical Environment (entimICE), a dedicated generator allows Define.xml for SDTM, ADaM and other datasets to be created with several mouse clicks from metadata domain definitions.
ODM Validator is a cutting-edge tool for content and structure validation of ODM files including define.xml. It contains more than 400 built-in checks.