ii4sm – End to End Pharmacovigilance Solution built on Semantic Interoperable Platform
ii4sm understands safety and together with market-leading partners delivers products and services that cover the entire value chain of pharmacovigilance, from data acquisition through integrated analysis, assessment and risk management.
ii4sm can advise clients to align and optimize drug safety processes and to enable successful outsourcing with seamless information flow. The depth of services can be tailored to the needs of the client companies, up to a complete turnkey solution including quality system, electronic database and operations outsourcing or spin-off. Powerful process simulation can test the improvement and optimize performance, compliance, cost and organizational footprint.
With a strong team of former drug safety managers from leading pharmaceutical companies (e.g. GSK, Roche, Amgen, Bayer Schering Pharma) and the experience with regulators such as the U.S. FDA, ii4sm creates the necessary basis of trust for our clients and ideally positions the company as a leader for the development of the gold standard in pharmacovigilance.
The complete end to end pharmacovigilance offer covers:
- Unambiguous data exchange based on semantic interoperability, maintaining the context of the data
- Access and exchange of data from multiple information models and sources within each domain of the healthcare sector
- ICSR case processing solution that codes and processes medicinal product adverse events in a semantically robust manner to enable more specific, comprehensive and automated analysis of the information
- Drug safety expert consulting with modeling & simulation software to improve quality, compliance, performance and cost saving in the drug safety / pharmacovigilance value chain
- Operations offshoring & spin offs of drug safety process