Electronic data capture (EDC) has changed the way industry conducts clinical trials. Investigators are now expected to use EDC for direct entry of clinical trial data. This acceptance of technology provides new opportunities for the distribution of clinical safety reports.
Based on the concept of EDC, ArisGlobal has developed LifeSphere® SUSAR Reporting (formerly known as agNotify), the first commercial software specifically designed to support the online electronic distribution of safety reports to all stakeholders.
Download this paper to learn about:
- Common challenges with safety-to-investigator reporting, including balancing quality and compliance with cost efficiency and productivity of resources
- The requirements for ensuring efficient distribution of safety reports, such as SUSARs and processes currently used
- How agNotify improves the process of informing investigators about safety issues
- Business benefits realized including saving time and effort in preparing letters to investigators, cost savings, greater control and real-time data to alert stakeholders to requirements with clinical safety reports
- Easy-to-use investigator portal gives investigators relevant safety information at a glance