ii4sm - Pharmacovigilance Operations, including Adverse Event Reports (AERs) Case Processing
To address increasing workload and requirements for integrated safety assessment and risk management, ii4sm offers a range of specialized services that permit real-time decision-making for sustained drug performance.
Case processing services:
- 2 business day turnaround with medical review & quality control
Scientific services:
- PSUR, ASR and risk management plan authoring
- Signal detection and evaluation
- Integrated risk assessment and management
- Management of complex safety issues
Pharmacovigilance consulting:
- Process, footprint and performance optimization utilizing sophisticated drug safety operations modeling and simulation tool
- Building a safety strategy and capabilities to meet future challenges
ii4sm services can be combined as necessary on a contract, spin-off or outsourcing basis. Whatever the choice, our streamlined processes offer high quality for the best price-to-performance ratio available on the market.
The real-life support ii4sm is providing through outsourcing operations and services to clients today is also flowing into the development of the ii4sm software solution making it incredibly attractive for all healthcare stakeholders who need to share information across companies, geographies, standards, and formats.
The application of semantics in healthcare on a highly standards-based platform is a significant innovation and an immense market opportunity to improve healthcare practice in the next decade. ii4sm provides consulting services to explore improvement opportunities in processes, information flows and analysis of data. The consulting activities include modeling and simulation as well as drug safety risk management and mitigation. In addition, we are actively participating in several Standard Development Organizations (SDOs) to ensure that emerging standards such as Common Terminology Services (CTS II) address the requirement of semantic interoperability in the life science domain.