Safety Reporting
Touchless from reporter to authority
Automation technology is already here
Safety reporting needs to follow
Managing safety reports is the core of pharmacovigilance. So far, this has been an incredibly manual effort and any automation attempts have focused merely on a part of the process.
That leaves the rest of the workflow still disconnected and, again, manual.
As a result, the PV world still requires endless hours of pharmacists or doctors to spend on mundane data entry for hundreds of thousands of cases.
Our all-encompassing integrated pharmacovigilance system under Tepsivo OnePV challenges that.
Completely streamlined from A to Z
Before a report even is received by a PV team, Tepsivo OnePV is in use.
This requires reporters such as local affiliates, partners, or investigators among others to submit the case in the right format of our Tepsivo OnePV case intake tool (or simply as a pdf file), whether those are spontaneous ICSRs, clinical trial SAEs, or anything else.
The process is fully integrated within Tepsivo OnePV and requires no effort of PV specialists.
Our highly experienced pharmacovigilance staff spends their time on quality control and mainly keeping the capacity allocated to value-added, scientific tasks.
It auto-populates the E2B R3 form in Tepsivo Safety Database from which the AE reports are submitted to authorities via fully standardized gateway connection.
The case intake module of Tepsivo OnePV automatically captures data directly or from a pdf file.
Completely streamlined from A to Z
The process is fully integrated within Tepsivo OnePV and requires no effort of PV specialists.
Our highly experienced pharmacovigilance staff spends their time on quality control and mainly keeping the capacity allocated to value-added, scientific tasks.
Before a report even is received by a PV team, Tepsivo OnePV is in use.
This requires reporters such as local affiliates, partners, or investigators among others to submit the case in the right format of our Tepsivo OnePV case intake tool (or simply as a pdf file), whether those are spontaneous ICSRs, clinical trial SAEs, or anything else.
The case intake module of Tepsivo OnePV automatically captures data directly or from a pdf file.
It auto-populates the E2B R3 form in Tepsivo Safety Database from which the AE reports are submitted to authorities via fully standardized gateway connection.
Touchless
with expert eyes on it
- investigators report directly into Tepsivo OnePV
- seasoned PV experts overseeing the process
- qualified scientists focused on value-added tasks
- dedicated customer support by Tepsivo PV managers
24/7 transparency
and inspection readiness
all AE reports
fully accessible at all times
automated audit trail
of all actions within Tepsivo OnePV
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
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.
150+
countries covered
100%
automation of routine tasks
50+
pharma companies on-boarded
millions
of EUR saved each year on PV costs
150+
countries covered
100%
automation of routine tasks
50+
pharma companies on-boarded
millions
of EUR saved each year on PV costs
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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