Tepsivo Safety Database
Your one place for ICSRs and SAEs
There is no justification for the high costs
that software companies charge for safety database solutions
The existing “safety databases” in pharmacovigilance industry irritated us for years.
Given these systems simply store data on adverse events and send those to authorities, it’s not just the price that feels inadequate: Case limits. Ease of use. Setup times. Data migration…
In a way, it is not even surprising some firms opted for an Excel as their database instead.
Most importantly, none of the solutions we’ve seen were even able to offer what truly makes a difference: an integrated workflow throughout the full PV system. So we changed that.
1,000€ per month
base rate for any number of cases
100%
legal
compliance
minutes
needed per case for full processing
ICSRs and SAEs possible to store & submit
Affordable. Convenient.
Tepsivo Safety Database
Affordable. Convenient.
Tepsivo Safety Database
1,000€ per month
base rate for any number of cases
100%
legal
compliance
minutes
needed per case for full processing
ICSRs and SAEs possible to store & submit
100%
legal
compliance
minutes
needed per case for full processing
ICSRs and SAEs possible to store & submit
Powerful integration with Tepsivo OnePV
service
150 + countries
Reporting
Intelligence
OnePV
Management
Powerful integration with Tepsivo OnePV
Tepsivo Safety Database is E2B R3, authority-gateway connected solution, fully immersed within the Tepsivo OnePV environment.
As such, you can expect major benefits from a seamless integration with the original case intake, reconciliation, or retrospective signal analysis and aggregate reporting.
Tepsivo Safety Database is E2B R3, authority-gateway connected solution, fully immersed within the Tepsivo OnePV environment.
As such, you can expect major benefits from a seamless integration with the original case intake, reconciliation, or retrospective signal analysis and aggregate reporting.
Touchless case processing
enabled by automation & AI
The speed of case processing is unmatched: from reporter to authorities essentially within minutes. This is thanks to our touchless case management, overseen by seasoned PV professionals.
All of this for sensible flat rates – regardless of the number of adverse events.
Seamless automation
from original case intake
Fully automated
reconciliation
Auto-population
of aggregate reports
Direct sourcing
of safety data into signal detection
Seamless automation
from original case intake
Fully automated
reconciliation
Auto-population
of aggregate reports
Direct sourcing
of safety data into signal detection
Further benefits of the safety reporting process
integration within Tepsivo OnePV are clear and include
Direct reporting of LCPPVs
24/7 oversight of all cases and related activities by EU QPPV or others
Smooth reporting of ICSRs, SAEs, SUSARs, or any other safety relevant information straight into aggregate reports
Centralized & standardized reporting from local affiliates or SDEA partners
Direct link to signal detection activities and reporting
Connection to reporting rules in 150+ countries
Streamlined reconciliation with any number of parties
Seamless flow of reports from Tepsivo Literature
Compliance reporting on all cases & other activities
Direct reporting of LCPPVs
24/7 oversight of all cases and related activities by EU QPPV or others
Smooth reporting of ICSRs, SAEs, SUSARs, or any other safety relevant information straight into aggregate reports
Centralized & standardized reporting from local affiliates or SDEA partners
Direct link to signal detection activities and reporting
Connection to reporting rules in 150+ countries
Streamlined reconciliation with any number of parties
Seamless flow of reports from Tepsivo Literature
Compliance reporting on all cases & other activities
All of the above taking place in one central digital system, removing the need for any admin workload associated with these. That is Tepsivo OnePV.
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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