Are your paper-based processes able to withstand the greater demand for faster, more complete AE data?
AE case data is collected from a diverse number of sources, both spontaneous and solicited, via processes rooted in paper based methodologies, designed prior to the digital age in which we now operate. In addition these cases often require significant follow-up to ensure all data required for regulator and internal requirements are collected. This complexity is further increased when local affiliates are actively involved in the safety data collection process, meaning individuals from very different backgrounds, such as Sales Representatives, Medical Science Liaison personnel, office based affiliate staff and call centres are required to record, translate and transmit AEs to central pharmacovigilance, followed by cycles of additional questions and data clarification. Does this sound familiar?
Would you like to increase data quality and completeness at first interaction?
Reduce manual effort and associated errors?
Using the latest innovative technology, the web-based Reportum® adverse event and product quality capture solution delivers rapid access to complete and standardised AE data, enabling accelerated knowledge and understanding of any potential emerging safety or quality issues. |
