DSURs are new, internationally-harmonized, safety documents (which became mandatory in European Union member states in September 2011) covering the safety summary of medicinal products during their development or clinical trial phase.
The new DSUR (defined in guideline ICH E2F) is based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase. The new DSUR format replaces the previous European Union ASR (Annual Safety Report) and the United States IND Annual Report.
Sponsors are required to submit a DSUR within one year of the Development International Birth Date (DIBD – the date of first authorisation of a clinical trial in any country worldwide) and provide annual DSUR submissions until all open clinical studies have ended (the final clinical study is completed and its study report has been submitted).
Trilogy is well placed to support our clients in all elements of DSUR and other safety document development.
Trilogy can also arrange full clinical review and sign-off, as well as published literature summary and analysis, and provide suggestions for company comments.