01 · Capture
Case intake
Email, web forms, call centre (MICC) and partner reports in one triage queue. Gen AI extracts the case fields for review.
OnePV by Clinevo Technologies
One case, one record, one system
End‑to‑end pharmacovigilance software with integrated Gen AI. Each case stays on one record from intake to E2B(R3) submission.
10+ years in the industry, trusted by 300+ clients, with 55+ inspections behind us.
Read the film's script
- A serious, unexpected adverse event arrives by email. Day zero. The fifteen-day clock is running.
- In many safety teams, that one case now crosses four systems.
- It's re-keyed, exported, reconciled and emailed between teams.
- Every hand-off costs time, and risks the data.
- OnePV does it differently. One case. One record. One system.
- Intake reads the email, and Gen AI pulls out the patient, reporter, product and event.
- The case is coded in MedDRA and WHODrug, then medically reviewed.
- Gen AI drafts the narrative. A safety physician reviews it, and signs.
- OnePV builds the E2B(R3) message from the same record, and submits it to the FDA, inside the clock.
- Every change is versioned, attributable, and in one audit trail.
- Built for 21 CFR Part 11 and EU Annex 11. Validation included. Support around the clock.
- OnePV, by Clinevo Technologies. Enterprise software, without enterprise costs.
Trusted by 300+ clients, including
What changes with one case record
In a typical multi‑vendor setup, one case is keyed, exported and emailed between separate tools. In OnePV every step works on the same case record.
| Stage | A typical multi‑vendor setup | In OnePV |
|---|---|---|
| Intake | Reports re‑keyed from email and call notes into a separate system | MICC, web, email and partner reports arrive in one triage queue, and Gen AI extracts the case fields for review |
| Processing | Coding, narratives and medical review handled case by case, across tools | MedDRA and WHODrug coding, Gen AI narrative drafts and medical review in one workflow |
| Submission | Exports reconciled by hand before every submission | E2B(R3) built from the same record and submitted to FDA, EMA, MHRA and Health Canada |
Six modules in one validated system
From capturing a report to submitting it and watching for signals.
02 · Monitor
Literature management
Scheduled PubMed and Embase searches. Articles are screened and tagged, and relevant ones become cases inside the safety workflow.
03 · Process
Safety database
ICSR processing, MedDRA and WHODrug coding, Gen AI narrative drafts and medical review, with a full audit trail.
04 · Understand
Signal detection
PRR, ROR and EBGM across your data plus FAERS, EVDAS and VAERS, with a recorded decision for every signal.
05 · Coordinate
PV agreements (SDEA)
Safety data exchange agreements tracked from signature to termination, with alerts before obligations and renewals fall due.
06 · Submit
Regulatory submissions
E2B(R3) reports built from the case record and submitted to FDA, EMA, MHRA and Health Canada.
One system for patients, medical devices, cosmetics and veterinary medicines.
Gen AI, checked and signed by your team
Gen AI takes the typing out of a case. Your case processors and safety physicians check what it extracts and approve what it drafts.
| Step | Gen AI drafts | Your team decides |
|---|---|---|
| Intake | Extracts the patient, reporter, product and event from the source | Checks every extracted field against the source |
| Narrative | Drafts the case narrative | A safety physician reviews it, and signs |
Every field change is versioned and attributable, with e‑signature where required.
Compliance and validation
IQ/OQ/PQ validation is part of every engagement, not a paid add‑on.
| Standard | How OnePV meets it |
|---|---|
| 21 CFR Part 11 | Built for. Every field change is versioned and attributable, with e‑signature where required. |
| EU Annex 11 | Built for computerised systems in GxP use, with a full audit trail. |
| GxP and GAMP 5 | Built for. IQ/OQ/PQ validation included in every engagement. |
| ICH E2B(R3) | Submission to FDA, EMA, MHRA and Health Canada, built from the case record. |
| GDPR and HIPAA | Built for. |
| ISO 9001 and ISO 27001 | Clinevo is certified for quality management and information security. |
From kickoff to live submissions
Our implementation team configures and validates OnePV, migrates your data and trains your team. Support continues around the clock after go‑live.
- Discovery and scoping
Your products, case volumes, reporting obligations, partners and current system.
- Configuration and validation
Workflows, reporting rules and roles configured, then validated with IQ/OQ/PQ.
- Data migration and training
Historical cases moved from your current safety database; role-based training for case processors, physicians and administrators.
- Go-live and support
Live submissions, with 24/7 support.
What two safety teams say
“Clinevo’s OnePV platform has been an indispensable tool for our pharmacovigilance operations. We process over 25,000 adverse events annually, seamlessly submitting to regulatory authorities such as the USFDA, EMA, MHRA, HC, and TGA.”
“With Clinevo Safety, we have transformed our adverse event reporting process. Submitting over 10,000 cases annually to the USFDA and EMA has never been smoother.”
See your own case in OnePV
Bring a typical case, anonymised or made up. We will take it from intake to E2B(R3) submission with you.
