Semantics Manager for Standards and Metadata Management

Semantics Manager™ enables enterprises to define, find, understand, use, and exchange data by managing standards and metadata as organizational assets. It is built upon an industry-leading repository and governance platform that can support requirements through configuration, rather than hardcoded behavior requiring custom modification to adapt to changing requirements. Semantics Manager enables standards development organizations (SDO) to develop, manage, obtain and incorporate reviewer input, and distribute standards more efficiently. It also helps industry to implement standards faster and more effectively while automating and improving business processes.


Increase Compliance With Industry Standards

Based on Object Management Group’s (OMG) Reusable Asset Specification (RAS), Semantics Manager’s metamodel definition infrastructure leverages the flexibility of declarative XML-based specifications to generate strongly-typed information models with full control over object type, object content and object-to-object associations. These generated models are presented to end users via a modern browser-based UI, giving them intuitive access to repository content organized in a format aligned with their user role. The base library includes an ISO-11179 based metamodel for managing metadata content.


Automate Governance Processes

A fully configurable governance process automation engine gives repository administrators control over object approval processes on a fine-grained basis, defining type-specific processes with content cardinality rules (e.g., information is optional for an object in draft status and mandatory in published status), inline validation policies (e.g., conditional content based on associated values) and role-based approval processes supporting any combination of parallel and sequential commenter and approver steps.


Address Clinical Development Challenges

  • Create, maintain, govern and use standards in a consistent manner
  • Know the impact of changes on other people, processes, or systems
  • Get maximum reuse out of existing data assets
  • Implement standards to improve processes
  • Minimize human intervention and interpretation when exchanging data

Create, Manage and Govern Content

  • Build content based on standards and/or standards-based templates (base library includes CDISC Terminologies, CDASH, SDTM, BRIDG, and associated data types).
  • Create content within context or as individual objects, including mapping and transformation logic
  • Define validations to enforce business rules & policies
  • Govern the creation and/or consumption of content, notifying the appropriate stakeholders throughout the process

Assess Impact

  • Understand relationships via graphical representation or automated reports.
  • Inform governance stakeholders of the impact of changes
  • Auto-assign tasks for stewards to indicate whether or not to inherit changes.

Easily Find, Use, Share & Integrate Content

  • Navigate content through configurable tree structures, interactive reference models, or customizable searches
  • Federate to other internal/external installations of Semantics Manager (including partners and SDOs).
  • Federate to other internal/external installations of Semantics Manager (including partners and SDOs).
  • Import/export content from the UI via multiple standard import & export formats (e.g., tab-delimited text, ODM, Define.xml) or build build custom importers and exporters

Analyze and Monitor

  • Take advantage of integrated open source reporting tools to view prebuilt and custom fully parameterized reports
  • Use the provided reporting views to build reports using any SQL-aware reporting tools
  • Surface reports dynamically within or external to repository
  • Share reports via multiple report export formats

Learn More

White Paper: Moving to a Standards-Based, Agile Clinical Development Lifecycle

As the BioPharma industry migrates from paper-based to technology-based clinical trials, it has the opportunity to make better use of the data it collects. Learn how Akana Semantics Manager helps.

Datasheet: Semantics Manager for BioPharma

Semantics Manager is an ISO 11179 compliant data governance solution built on the Akana industry leading metadata repository and governance platform, prepopulated with CDISC and BRIDG standards.
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