ii4sm - Safety Assessment and Risk Management, Clinical Quality Assurance Services, Modeling & Simulation Software
To address increasing workload and requirements for integrated safety assessment and risk management, ii4sm offers a range of consulting services that permit real-time decision making for sustained drug performance.
We are delivering operational services in GCP Clinical Quality Assurance to further develop capabilities based on the semantic interoperability platform that take advantage of the traceability and transparency provided by its Service Oriented Architecture (SOA). These GCP QA-related data can be used to anticipate risks to procedural integrity of clinical development processes and assist in the targeting of audits. Currently, without these platform capabilities the GCP CQA-related risk predictions can only be performed manually and not in standardized manner. The lessons learned through operational service are a valuable asset directly affecting our software development and deployment at client’s premises.
To ensure that ii4sm software applications serve client’s critical needs, we mirror the same operational activities that our clients complete every day. This is necessary to guarantee that the software we provide addresses the subtle realities, the procedural exceptions and the real-life complexity that characterize the daily pharmacovigilance business. At ii4sm we process ICSR cases, manage operational tasks and adjust to changes in real-life workflows while maintaining compliance and understanding the limitations and challenges that our clients face. We perform risk management and mitigation planning to help our clients designing optimal drug safety workflows.
Proprietary and innovative modeling & simulation software is used to analyze existing and design optimized processes for companies or departments active in pharmacovigilance.
As an independent, strictly neutral partner interacting with various players in healthcare and life sciences, ii4sm is the ideal interface for pharmaceutical companies, health insurers, health providers, regulatory authorities and academia.