Confidence Beyond Compliance
Clinical trials play a crucial part in any clinical development programme. As well as gaining information on a product’s efficacy, they also have 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.
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 using FDA’s AERs, as well as the World Health Organization (WHO) data, report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the national Competent Authorities and Ethics Committees, 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. We can also provide;
- adverse event analysis to drug safety profiles
- comprehensive synthesis of pre- and post- marketing adverse event data
- OTC switch safety data analysis and strategy
- hazard assessment for potential product recall
- causality assessment protocols