ICSR and SUSAR / SAE Management
– comprehensive services for adverse event reporting –
The entire reason for pharmacovigilance’s existence is to collect, record, and assess reports on adverse events to medicinal products. Whether to process Individual Case Safety Reports (ICSRs) for medicines on the market, or Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) during clinical trials, you will need a reliable provider to ensure these are always managed efficiently and reported to authorities in time.
With our high focus on efficiency, streamlined processes and smart tools, Tepsivo can easily be your right provider.
We can cover the entire process from adverse event intake to submission to authorities and later signal management. No matter the volumes, we can always offer the most efficient solution, with adaptable commercial models for each customers’ specific situation and number of received adverse event reports.
How do we do it?
Following our light and transparent process using modern technology to always allow easy access to data in real time as well as retrospective data analysis.
Our focus is on cutting away needless steps and eliminating overhead admin work around assessment of cases – thanks to which we can reduce the time spent per case and in total on your overall case management.
The bigger the volumes, the more time and costs saved.
Global Adverse Event Report
Digital Platform
With our complete solution, you can reap the benefits of a fully streamlined process, end-to-end, across your organization, and all its affiliates around the world.
All in one place. All with unified reporting. All in Tepsivo Platform.
Intake
Your teams in sales, medical information, quality, manufacturing and anywhere else, can all enjoy an intuitive online reporting form for any potential AE reports. Any such report is then automatically entered into our Tepsivo Platform where we can track the case and validate as an ICSR.
Whether or not you are able to apply our solution in non-pharmacovigilance functions of your company, you will still see great process improvement with our system.
Tracking
In our safety reporting module, all safety relevant information and potential ICSRs are tracked, with automated audit trail of all actions. At all times, you will have a clear overview of all safety relevant data as well as ICSRs/SAEs and their deadlines for submission. Furthermore, the individual reports can be linked directly to the signal management module where you can validate and analyze any potential signals.
On top of this, all safety information is reconciled with your SDEA partners in an automated report pulling the tracked data in any given month.
All the while saving many hours throughout the process, as opposed to traditional methods applied by typical CROs and PV vendors.
Assessment, Validation & Submission
All potentially safety relevant information is assessed by our team of trained pharmacovigilance specialists with QC implemented for each case, assuring a close attention is paid to any information that may indeed be relevant to your medicine’s safety profile.
Any validated ICSRs are then transmitted to our inhouse safety database where a complete E2B R3 form is completed, again with QC, and submitted through our gateway to EMA, FDA, and to other relevant authorities around the world.
Any non-validated cases are kept as potentially safety relevant and used for retrospective analyses.
Maintenance
After submission and acknowledgement, the initial safety report form is updated and maintained for later purposes such as signal management or PSUR development, with the ability to link individual ICSRs or other safety relevant information with additional signal analysis/aggregate reporting modules of our Platform.
Follow-up
At any point throughout the cycle, a follow-up with the initial reporter may be required. It’s all much easier to do with an online follow-up form linked in our Platform directly to the original case, all follow-up cases being tracked in the same place and linked with initial cases, allowing clearer visibility across the full volume of intake cases.
Automatic reminders for scheduled follow-ups also come in handy.
Complete Transparency
In our system, you will always have real time access to all data, including all Adverse Event Reports, Adverse Drug Reactions, Individual Case Safety Reports, SUSARs, and others.
In your Customer Dashboard of the Tepsivo Platform, all information is summarized for your quick overview and peace of mind that all cases are processed and submitted on time, ensuring you meet your legal obligations.
Let’s have a chat
Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.
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