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.