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ii4sm – Context for Healthcare, Applications based on Computable Semantic Interoperability

Based on a new generation of software technology, the ii4sm interoperable system is facilitating the provision of relevant safety data for a holistic assessment. The system operates within a hosted environment accessed via a secure internet browser interface that requires no complex installation or upgrades on the client’s part. ii4sm provides the necessary services to migrate data with the administrative, medical, scientific and administrative expertise to deliver a turn-key solution.

The ii4sm semantic interoperability platform can power numerous healthcare applications. The first application that ii4sm is bringing into the healthcare market is drug safety, offering the following unique benefits:

Connecting people to unleash the power of a team

  • End to End – one integrated system for global organizations that addresses all aspects of the process
  • Ease of use – brings information and tools to the user when needed through intuitive interfaces for all activities in the process
  • Communication – connects all stakeholders in the process through sophisticated and meaningful communication capabilities
  • Workflow – supports and simplifies the complex workflow of rapidly changing organizations on a global scale including capacity and footprint management


Connecting data to unlock the power of information

  • Context – integrates tactical tasks, for example in the case management of adverse event reports on drugs, in a strategic context of understanding the safety profile of the product
  • Signaling and risk management – organizes and accounts for data to support on-line and real time signal detection and risk management activities for drugs
  • Integration – the platform can be leveraged to evaluate the same medical concept across other sources of data beyond the ICSR*, integrating internal (clinical development) and external (epidemiology, electronic Health Records) data sources to support an efficient and comprehensive approach to pharmacovigilance


Resolving quality, compliance and cost issues

  • Quality – driving to the right data for the right case and automated checks of data consistency and correctness address quality
  • Compliance – integrated end to end workflow and communication provide high performance to assure and demonstrate compliance with regulations
  • Cost Reduction through Automation – semantic robustness allows automation of complex activities (e.g. medical assessments) in a regulated environment with reliable escalation mechanisms



*ICSR = Individual Case Safety Report