A Development Safety Update Report (DSUR) is a concise yet comprehensive analytical report, presenting the assessment of risk and any changes, in accordance with previous knowledge of the safety of the investigational drug. The DSUR is now a legal requirement in the European Union (EU) and widely accepted by Regulatory Authorities outside of the EU including the FDA and Asia Pacific. The format widely accepted is in ICH E2F.
The report should be submitted at yearly intervals from the year of the Development International Birth Date (DIBD – the date of first authorisation of a clinical trial in any country worldwide).
The DSUR can be a complex document but Bionical Emas have extensive expertise in house with 15+ years’ experience in writing these aggregate reports, covering all elements of DSUR and other safety document development such as line listings.
Bionical Emas can provide a consolidated safety reporting system, together with the in-house expertise to produce an accurate report for the Regulatory Authorities and Regional Ethics Committees. Bionical Emas can produce DSURs as standalone projects, as well as part of a pharmacovigilance service for full service clinical trial programmes.
Having produced over 70 DSUR’s/Annual Reports, all submitted on time and accurately, clients can be sure that their study DSURs are in safe hands with Bionical Emas.