In a few weeks’ time, the “PhedaKliFo”, a modular extension of the Pheda pharmacovigilance database, will go online.
The new DSUR module enables contract research organizations and sponsors of clinical trials to export the tables in accordance with the ICH E2F Guideline. Line Listings, DSUR Summary Tabulation and the exposure tables can thus be output by age and gender, ethnic origin and cumulative exposure at the touch of a button. The database’s search function allows a wide range of options for querying study data – separated by study or other freely selectable criteria that can be added to the query. Furthermore, additional columns can be added to the export tables and exported.
In the next Heacon newsletter we will present the new Pheda module in detail. You can find out more about our pharmacovigilance database “Pheda” here .
