End-to-end Serious Adverse Event (SAE) processing
We provide complete end-to-end case processing of all your SAE and other reportable adverse events of special interest.
Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting
We appoint a dedicated person responsible for SUSAR reporting globally, as applicable (e.g. in EMA’s EudraVigilance system, MHRA portal, etc.). We are experts at preparing expedited safety reports, including cover letters and global EV and non-EV submission of SUSARs to Competent Authorities, Ethics Committees and Investigators, to the relevant regulatory intelligence reporting requirements.
Medical Dictionary for Regulatory Affairs (MedDRA) coding
Coding in 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.
Our experienced safety physicians can assess all your reported SAEs and SUSARs. This includes narrative review of MedDRA coded terms 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.
We provide medical monitoring from protocol writing to final analysis throughout your trials, and are available 24/7 as needed to answer medical queries from sites (e.g. inclusion and exclusion criteria).
Our medical monitors are experienced physicians and will monitor the study data closely for medical accuracy and identify and escalate any trends to the sponsor that potentially impact patient wellbeing and safety, including any events of special interest.