avaAdverse
Automated import of safety-related information from national authority databases, digitalized data evaluation and easy integration into clinical evaluation and risk analysis
Easy search, appraisal and analysis of safety-related information directly in Polarion
avaAdverse is an add-on product to avaClinical, our product for the digitalized clinical evaluation process. It is used for efficiently searching and evaluating published safety information such as adverse events, recalls or field safety corrective actions (FSCA) from various national authority databases. The digitalized documentation in Polarion ensures efficient data processing and creation of reports as well as seamless traceability to information in other processes, such as Clinical Evaluation, Risk Management, PMCF and PMS.
Features of avaAdverse
- Central management of all searches and search results from national authority databases: Save time with automated interfaces to FDA databases and easily import data from manual searches, e.g. MHRA and Swissmedic, via Excel.
- Automated search and import of safety-related information provided in the FDA MAUDE and Recall databases into Polarion: Eliminate manual data transfer activities.
- Evaluation of safety datasets directly in Polarion: Analyze and appraise each data set on a central overview page and save time with automatically generated overview tables in report documents.
- Direct link to information in interface processes: Create links between data evaluations to information in the clinical evaluation, risk analysis, PMCF or PMS and demonstrate that identified safety datasets have been used as input for other regulatory processes.
- Completeness of information: Ensure that nothing goes missing and documents are complete with the help of built-in traceability reports that highlight missing information, e.g. required for data appraisal.
Your contact partner
Derek Crow