entimICE - Entimo Integrated Clinical Environment

entimICE

Entimo Integrated Clinical Environment or entimICE is a metadata-driven and configurable product suite with seamlessly integrated, model-independent metadata repository (MDR) for standards governance, high-performing clinical data repository (CDR) for data management, multi-language statistical computing environment (SCE) for analysis as well as numerous productive tools along the entire clinical study lifecycle.

Metadata-driven, configurable and modular

entimICE is a completely metadata-driven and modular enterprise solution. All artifacts are stored in the central repository, and are searchable and accessible for employees and external partners: entimICE provides both a rich client and a web-based User Interface for access to the repository. The integrated metadata repository module stores a comprehensive library of reusable artifacts for the user community, thus dramatically increasing re-usability and driving process automation. A built-in version control system provides an effective means to browse and restore past versions of all repository artifacts including data and programs, if required. entimICE is a 21 CFR Part 11- and ICH GxP-compliant solution which makes available all necessary tools to support full-fledged traceability of critical user and system activities.

Transparent governance process

The central repository provides a single, shared view of information for all authorized users. The solution allows flexible definition of lifecycles for every artefact type stored in the repository and guides users through the defined lifecycles and workflows. Lifecycle status changes can be combined with electronic signatures and automatic notifications. Such features as links to standards and metadata, discussion forums and dashboards can be integrated into lifecycles by configuration.

Improved collaboration across repository

The solution improves communication between external partners and users within the organization through such collaboration features as electronic change requests, queries, task lists, dashboards, and notifications, it establishes a true collaboration environment with an efficient, paperless change management process. External partners with permissions can access defined areas and easily down- and upload objects. All user activities are tracked by the solution and can be reported, if necessary.

 Business scalability with on-demand features

As a modularized and configurable platform, entimICE provides the customer with flexibility for on-demand features and supports agile methodology. The default configuration can be up and running within a short time at full power. In the course of the configuration workshops, it can be re-configured to reflect more precisely the customer’s processes and workflows. Additional modules can be licensed on demand and are easily activated in the configuration.

 

Easy interfacing and high security

entimICE is based on the open architecture concept and supports easy data and metadata exchange with third party products based on database access via SAS views, direct database access, web services and information exchange via staging areas. Analytic software - such as SAS, R and SPLUS - is tightly integrated, with full traceability. External reporting and BI tools such as J-Review, Spotfire, and other 3rd party analytic tools can be easily connected to entimICE via the interfacing methods described above.

Despite its openness, entimICE is a highly secure environment which granularly controls access to the repository for users and external systems down to the folder, artefact and even row level, based on configurable roles and groups.

Interactive data analysis

entimICE offers a Web Logon possibility to enable any type of external tool file access. This is the starting point via Web Service to open parts of the file system repository for access by any 3rd party tool. An 'out-of-the-box' Interface Web User Interface is available for entimICE DARE 4.2 to use these Web Logon Services. With Web Logon Services, the whole bunch of interactive development experience provided by the world of professional analytic software is now open for the entimICE users with full respect of their access privileges.

Unified programming environment

The ultimate goal of the solution is to provide a unified programming interface for SAS, R, SPLUS and SQL with access to integrated flows of data from heterogeneous sources. It offers a broad range of productivity tools which speed up the program development process and make it more robust. An existing code base can be easily migrated into the repository. All programs can be executed in online, batch, scheduled batch and periodic scheduled batch modes with full traceability of program runs and retrieval of server logs and results. The solution makes such objects as macros and formats available along defined search paths.