With the new legislation in global territories, the ability to obtain and submit quality single case AEs/SAEs in a timely manner has become problematic. Additionally, as more and more emphasis is placed on signal detection across studies and compounds, the change from single case to methodical compound or study level assessment has required a different mindset in collection of AE and SAE information. Companies are required to monitor and submit AE/SAE reports to multiple agencies who now require different methodology in reporting. Additionally, with increased scrutiny and monitoring from the agencies, the number of regulatory requests regarding AE/SAE has dramatically increased, while the timeline to response has decreased.
Meeting these requirements can be costly, time consuming, involve more intensive attention to detail, and a better understanding of the compound and its targets to be able to understand and differentiate between the effects of the compound and disease or comorbidities. Failure to understand these differences can result in a company receiving a failure to submit or having a compound taken off the market.
Our professionals have experience working within the industry for decades in both single case assessment, signal detection, and as part of the submission team. We follow global, regional, and local reporting requirements to ensure compliance and timely submissions. Additionally, together with our clinical colleagues, we monitor the clinical studies for early detection of potential risks so they can be identified and mitigation be put into place. This ensures that studies are only stopped for noticeably short periods of time, since we can negotiate with the global authorities simultaneous to the report being sent through. Additionally, since we are able to monitor the events in real time, we can initiate our Risk Management Plans with First in Human studies and build on it through study phases, submission, safety update (120, 150, 180 day updates), regulatory required safety updates (DSUR, ISS, PSUR, PBRER) and post marketing.
Since we use single entry, your sites will only enter information once into the clinical database. The data will flow directly from the clinical database into the Safety reporting E2B Plus fields allowing for the information to be integrated into our cloud based safety system and subsequently into whichever database our client is using. All safety queries will be transparent to anyone working on the study.