SAE and SUSAR Management.
Peace of mind with our complete safety data management service.
Serious Adverse Event processing.
We provide end-to-end case processing of all your SAEs and other reportable adverse events of special interest.
We appoint a dedicated person responsible for (SUSAR) reporting globally as applicable for EMA, MHRA, FDA etc.
We are experts at preparing expedited safety reports, including cover letters, electronic submission, and local submission of SUSARs to Competent Authorities, Ethics Committees and Investigators, as per the relevant regulatory reporting requirements.
Our experienced safety physicians can assess all your reported SAEs and SUSARs including: review of the Medical Dictionary for Regulatory Activities (MedDRA) coded terms, narrative review and determination, and documentation of the Sponsor Causality Assessment. This can be done independently from your operations, or in close collaboration with your in-house safety physician or medical monitor.
Coding in the Medical Dictionary for Regulatory Affairs (MedDRA) is mandatory in most regions worldwide, and we provide a complete up to date MedDRA coding service for the processing of all case reports.
Translations to/from local languages.
Clear and accurate communication is critical when dealing with clinical safety data and we can handle all translations to/from local languages as part of the case management process e.g. autopsy reports.
Following the Reconciliation Plan, we support any ongoing or final reconciliation between the Clinical and Safety Databases, working together with your Clinical Data Management team.
What our clients say about us.
I have to say that everything has been really smooth with Arriello, and your team has shown a really good disposition since the beginning. Your big experience and knowhow are very important for us also.
I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.
Thank you very much to you all involved recently providing the necessary additional audit documents requested by the authorities. Your support was instrumental in successfully finalizing a process that started back in February.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.