entimICE DARE - Data Analysis and Reporting Environment

Mission

entimICE® DARE - Data Analysis and Reporting Environment - is a metadata driven statistical computing environment (SCE) with a tightly integrated data repository (CDR) and metadata repository (MDR).

The ultimate goal of the solution is to provide a broad range programming support for SAS, R, SPLUS, SQL and the world of other analytic tools with access to integrated flows of data from heterogeneous sources and value-adding tools. The product facilitates data management and statistical programming by integrating data sources and tools in one unified environment. Numerous robust tools help you manage your data, metadata, codelists, programs and documentation and provide for audit trails, versioning and lifecycles along the entire process. DARE allows to transform and query data, run programs, produce regulatory and management reports as well as submission packages in a fully controlled and traceable manner.

 

 

Benefits

1. High security of your data and metadata: With DARE, you find all data, metadata and tools in one secure place. Role- and group-based permissions are controlled down to the record level.

2: High-performing analytical experience: With Teradata or Hadoop backend, DARE is able to integrate even Real World Evidence data as well as other data sources like financial or safety data into clinical analysis.

3. Transparency and compliance of processes: With DARE, you can be sure to smoothly fulfill regulatory requirements, including the FDA 21 CFR Part 11 and ICH GxP. Audit and status reports are just one click away. The solution natively supports the latest clinical standards including CDISC ODM, CDASH, SDTM, ADaM and Define 2.0.

4. Reduced administration effort removes the burden from the IT departments.

 

 

What is new?

Entimo continuously develops and improves its products. Here is just a small selection of enhancements in the current release:

  • Multiple metadata import from Medidata Rave
  • Incremental data access from Medidata Rave
  • Import/export via FTP/SFTP
  • SAS encoding conversion
  • Interactive programming with R, SAS and other tools
  • Interface with Spotfire Analyst
  • Excel as report output format
  • Enhanced scripting API
  • Priority system for jobs
  • New system reports to enhance traceability
  • Reworked search engine
  • Full Define.xml 2.0 support
  • Teradata as optional repository backend
  • Enhanced optional indexing server

 
Contact us for more information about Entimo's products, release information and roadmaps.

Dare Highlights

Secure repository

The central repository provides a single view on information for all authorized users. Data can be stored in the data warehouse as well as in the file repository as datasets in native formats, thus supporting different customer philosophies. Numerous productive tools to manage data, metadata, programs, macros, codelists, reports, documents and even images are available in the system and boost the users' productivity. An exceptional feature of the solution is its ability to automatically track and report the dependencies between elements in the process. This eliminates the daunting efforts required to manually insure that all dependent objects are consistent and up-to-date.

High-performing analytics

As a high-performing data repository, DARE offers a completely new analytical experience for statisticians and data scientists: With Teradata or Hadoop backend, DARE is able to integrate even Real World Evidence data as well as other data sources like financial or safety data into clinical analysis.The combined solution provides a highly scalable option for data storage and analytical processes.

Easy connectivity to external data sources

External data sources like EDC, CDMS, CTMS and EDMS can be easily connected with DARE via JDBC. Available data can be imported into DARE or directly accessed in external databases – dedicated wizards help you get the information into the environment with minimal effort.

Metadata repository

entimICE DARE contains a tightly integrated metadata repository that supports governance for all types of metadata including specifications, e-protocol and data elements, domains, codelists, analysis and reporting metadata as well as a variety of other metadata types. Authorized users can create new and modify existing metadata categories and metadata definitions. It is possible to define and group metadata at multiple levels- – as metadata items or collections from global via specific configured hierarchy levels down to the study level.. The system provides powerful tools to extract, collect, manage, link, search and exchange metadata. Due to such flexibility, the environment supports handling of standardized metadata like CDISC models, as well as company-specific models.

Semantic search engine

By using the robust search facility, users can define, store and run simple and complex retrieval queries. They can search over parts or over the full range of object types, their metadata, lifecycle states, history and values within the repository. Users can even integrate queries and their search results into automation processes. A highlight of the search engine is its ability to search through links and dependencies - entimICE search provides a shortcut to required results.

Lifecycle management

The system supports the configuration of lifecycles for all repository elements. Available actions can be activated only in particular lifecycle states, thereby preventing misuse. Changes to lifecycle states can automatically trigger other actions or notifications - a powerful communication tool, particularly for distributed teams, which keeps them up-to-date.

Version control

Every object managed in the repository can be placed under version control. Data, metadata, programs, properties and links are subject to versioning as well. The user is able to retrieve older object versions, view them and export them to the file system. You can compare text-based elements, browse and navigate between differences using a built-in comparison tool.

Validation support

With a comprehensive validation function, validation criteria for study objects can be defined to support corporate QA requirements. The validation criteria can be grouped into categories and integrated into the object lifecycles.

 

Automated workflows

The system provides a graphic workflow facility. The tool allows assembling task sequences fully supported by drag-and-drop user interaction. In this way, you can easily define long workflows enriched with imports, exit conditions, notifications, status changes, exports and other functions. The user can define parameters with the workflows to make them reusable in different contexts.

Comfortable program development environment

entimICE DARE provides an integrated program development environment (IDE) for SAS, R, S-Plus and SQL. Users can develop and execute programs in one unified environment. In addition, almost every external editor is supported and can be used with DARE. Previously developed programs and macros can be effortlessly loaded and immediately become executable in a controlled manner. You can run programs and code snippets locally or on the server, online or scheduled, on a one-time or continuous basis. Standard macros and programs can be accessed via search paths and don't need to be copied.

Access to entimICE data for interactive programming

Via Web Logon entimICE enables file access to any data by any type of external interactive programming tools. All configured access rights on data are respected. An 'out-of-the-box' Interface Web User Interface is available for entimICE DARE 4.2 to use these Web Logon Services. With the Web Logon Services entimICE users can work with tools like R-Studio, SAS Enterprise Guide or Spotfire on their entimICE hosted data and can store and exchange programs and results.

Audit trail and execution tracing

The system makes available all the tools necessary to support traceability of user and system activities. The system tracks changes to data, structures, relations and user access rights. Moreover, DARE monitors program executions and detects all libraries, program parameters, specified and actually used input and created output objects. Change history, audit trails and execution traces are stored in the repository so they can be easily retrieved and reported later on. DARE ensures the retention and availability of all data and metadata necessary to examine or to reproduce past runs at any point in time.

Management of standard terminology

entimICE DARE is able to manage controlled terminologies, codelists and external dictionaries including CDISC codelists in a consistent way. The tool not only handles version control, audit trail and other traceability aspects, but also allows direct access to the codelists stored in the repository via search paths, thus eliminating the need to copy them across the hierarchy.

Study reporting

A cornerstone of the entimICE solution is its powerful and flexible reporting engine. The reporting module is based on configurable templates and can be adjusted to reflect particular corporate designs. The reports can be generated and exported in different formats. For most reports HTML, PDF, XLS and RTF are natively supported.

Reduced system administration effort

The system allows the user to intuitively administer study structures as well as other organizational entities. The full study tree can be planned in advance including standards and access rights, thus reducing redundant work and guaranteeing name consistency and compliance with standards. A complete structure for a new trial can be created from one of the available templates in a short time. Administrative changes can be immediately promulgated in the whole system, if necessary.


Download the fact sheets: entimICE DARE CDR | SCE or entimICE DARE MDR

Metadata goveranance

Clinical data elements

Data and metadata

Data and metadata in one place

Program development

Program development environment

Automated workflows

Automated workflows

Lifecycle management

Lifecycle management

Execution trace

Program execution trace

Audit trail

Audit trail