A clinical trial is a crucial part of any clinical development programme and as well as gaining information on a product’s efficacy, it also has a similarly important role in furnishing information on safety. The process for the gathering and reporting of these trial data must conform to regulatory requirements.
How can we help?
We have many years’ experience in developing robust clinical study safety processes. We can design and implement safety procedures, create and review Serious Adverse Event narratives, report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the national Competent Authorities and Ethics Committees (both within and outside of the EU), as well as create and submit Development Safety Update Reports (DSURs). In addition, we can advise on or create safety updates to Investigator Brochures and Investigational Medicinal Product Dossiers (IMPDs) or create bespoke safety reviews in response to regulatory authority requests.
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION