Tepsivo Safety Database
It’s finally here. Finally a real challenge to big corporations
taking advantage of historically dominant position on the market.
There is a new, modern, solution to meet every pharmaceutical company’s needs of setting up and maintaining a pharmacovigilance safety database for ICSR management – in line with our ethos of keeping things as simple as possible, we call it Tepsivo Safety Database.
And simple it is. Designed to make it painless to meet regulatory requirements with an easy-to-use interface and appropriate pricing, it meets our criteria of a system that can help make PV a value-based field of healthcare.
Having a safety database of course is not a regulatory requirement but it’s clearly a practical thing to have. And most practical with a clean, straightforward UI and pleasant UX, allowing the work behind ICSR data entry to be just a bit less tedious (or bit more fun, depending on your outlook).
Core features
Seamless ICSR data entry
•
E2B R3 (and E2B R2) format
•
ICSR database
•
ICSR electronic reporting
Safety database electronic submissions gateway
to regulatory authorities:
EMA and EudraVigilance
FDA and FAERS
MHRA and MHRA ICSR portal
Validation package of documents to meet legal
requirements on computerized system validation
Workflow management
•
UCUM items dictionary
•
User Management
•
File Attachments
And… the possibility of connection with the world’s only fully digital PV system run by Tepsivo Platform – that is the killer feature!
Tepsivo Safety Database is a ready product, but our software developers keep working on it every day and all our customers can enjoy regular update and improvements to functionalities.
Cost efficiency
Our core objective in pharmacovigilance is to shrink the size of the industry as it’s become unnecessarily overpriced with too much time effort involved (without good reason!). While this is contrary to what all other providers do, we strictly stick to it with all our services and products – Tepsivo Safety Database is no different.
We offer fixed monthly rates depending on the size of your company and what we calculate as our added value to you and your pharmacovigilance team. We’re not ones to pretend that number of users or amount of ICSRs somehow increase our costs – those files aren’t as big as to substantially impact the cloud data storage we pay for.
We know you can’t (and shouldn’t) really influence the amount of ICSRs you deal with, and so it shouldn’t be your concern to worry about case limits for your safety database costs. You should also be free to have as many users in the system as you like.
Have a look at our pricing here
or feel free to reach out directly for more info.
Technology
We don’t pretend this is an advanced technology, because there’s absolutely no need for one. We can talk about AI all day long but until it’s as sophisticated as to truly make any meaningful impact in reducing heavy workload, let’s not pretend there is a real, helpful, use of AI within case processing. Don’t buy into such claims from providers who just try to justify a higher price for their software.
Even so, Tepsivo Safety Database is still the most modern PV database on the market; being actually built on a real modern database, not software from the 90s.
Even so, Tepsivo Safety Database is still the most modern PV database on the market; being actually built on a real modern database, not software from the 90s.
What the industry needs is a solution that can help reduce ICSR processing time with intuitive interface and connection to case intake and later signal analysis – all within one, genuinely end-to-end solution.
In combination with our unique Tepsivo Platform, that is what our complete offer is.
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.
Tepsivo Oy | Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | [email protected] | +358 402 204 698 | Privacy policy
