Quality Risk Management Services
“Improving operational processes by proactive risk management“
By utilizing our QRM Consulting Service, your company is guided around detected risks and obstacles specific to your organization. These services provide your company with customized solutions and consulting resources for your particular business objectives. By supporting you in assessing and managing clinical development risk factors, our consultants leverage company resources and create significant value. This allows you to carry out risk-based study evaluations. These can be tailored to specific risk areas (e.g. study set-up, trial sites, service providers and others) and risk types (regulatory compliance, protocol adherence, quality and performance).
Benefits
Earlier risk detection enables: more time to correct, avoidance of costs and protection of reputation
Safeguards clinical development investments, by improving operational performance through frequent risk assessment and mitigation procedures
A broader reach leads to comprehensive issue detection, a quantifiable overall risk exposure and the ability to focus limited resources on high risk areas
Enables deeper insights by identifying trends and patterns, differentiating central and local issues that ultimately lead to process improvements
ii4sm’s Quality Risk Management Services are applicable to various risk areas, such as:
- Study Design and Setup
- Trial Sites, Central Lab, and Affiliates
- CROs and other Service Providers
- Data Management
- Drug Safety
In conjunction with our other products: Quality Risk Radar and the GCP Compliance Utility,
the QRM Consulting Service further enables:
- Targeted Monitoring of Trial Sites
- Streamlining of monitoring activities to reduce visit complexity and cost
- Learn more about ii4sm`s Quality Risk Management Services: Please contact us at This e-mail address is being protected from spambots. You need JavaScript enabled to view it