Live Scan
Runs your product search strategies against published literature (PubMed/Medline) on a schedule and screens every new article for adverse-event content.
Learn more about Live ScanPharmacovigilance services · CRO · platform
Edriza: end-to-end pharmacovigilance on a single platform
Literature, local journals, mail, intake ICSRs and documents to a XSD-checked E2B(R3) XML and submission. One platform: no separate tools or extra subscriptions for literature screening, case processing, QC, E2B generation, submissions, aggregate reports and signal detection.
Two independent AI agents plus a QC agent on every case; your experts stay in control.
One platform
One sign-in, one audit trail, one data set from source to submission
- Literature monitoring
- Local journals
- Mail box
- ICSR intake
- Document scan
- E2B(R3) XML
Projects delivered
7+
Partners
9+
Edriza platform
Human oversight
One platform, from source to submission
AI reads and enters the data, two independent AI agents and a QC agent check every case, and your experts decide where a decision is needed.
2 + QCAI checks per case
E2BR3 XSD-checked XML
AuditEvery decision
Compliance & quality
Built to support 21 CFR Part 11 and EU GMP Annex 11 requirements
Audit trail, electronic signatures, access control and record versioning are part of the platform, not add-ons. Validation documentation is available on request.
01Audit trail on every decision: who or which agent acted, when and why.
02Electronic signatures with re-authentication for signed actions.
03Role-based access, two-factor sign-in, session time-out and separated client data.
QUALITY CONTROLS
✓ ICH E2A / E2B(R3) / E2D aligned
✓ GVP Module VI aligned
✓ E2B(R3) XML checked against the XSD
✓ MedDRA coding
✓ Versioned SOPs, independent approval
End to end
From any source to submission, in one flow
Sources: literature (Live Scan), local journals, your mail box, intake ICSRs and uploaded documents. Each case moves through the same steps, and every step is recorded.
- 01Source
- 02Product check
- 03Validity
- 04Seriousness & causality
- 05Data entry
- 06QC
- 07E2B(R3) XML
- 08Submission
The platform
Every pharmacovigilance module in one place
Literature monitoring, ICSR case processing, E2B(R3) reporting to regulatory authorities, aggregate reports (PSUR/PBRER) and signal detection. Use the modules you need: they share one case database, one audit trail and one way of working.
Local Journal
Monitors the local and regional journals you subscribe to, as GVP Module VI expects for the countries where your products are authorised.
Learn more about Local JournalRA Monitoring
Watches regulatory authority websites for safety communications and regulatory changes that concern your products and your PV obligations.
Learn more about RA MonitoringMail Box
Reads your safety mailbox, sorts each mail, picks out new ICSRs and follow-ups and links them to the right case.
Learn more about Mail BoxIntake
Receives ICSRs from partners and other intake channels and runs them through the same checks as every other source.
Learn more about IntakeDocument Scan
Reads uploaded documents such as full-text articles, source forms and partner reports, and extracts the case data.
Learn more about Document ScanAggregate reports
PSUR, PBRER, PADER and DSUR built from your case data: line listings, summary tabulations and a draft for your experts.
Learn more about Aggregate reportsSignal detection
Detects and tracks signals in your case data and literature, with the GVP Module IX workflow from validation to action.
Learn more about Signal detectionSubmissions
Builds the E2B(R3) XML, checks it against the XSD, submits it to the authority or partner and tracks the acknowledgement.
Learn more about SubmissionsWhy a single platform
No hand-offs between tools
Literature screening, case processing, QC, E2B generation, submissions, aggregate reports and signal detection run in one platform, with no additional subscriptions needed for them.
Separate tools
A hand-off at every step
Each activity in its own system, with its own sign-in, its own copy of the data and its own subscription.
Edriza
One platform, from source to submission
Two independent AI agents plus a QC agent on every case; your experts stay in control.
One sign-in
Your team works in one place, with one set of roles and permissions.
One audit trail
Every step of every case is recorded in the same trail, from the source to the submission.
One data set
Cases, aggregate reports and signals use the same coded data, so the figures agree.
No extra subscriptions
No separate tool to buy for literature screening, E2B generation, submissions, aggregate reports or signals.
Standards
ICH and GVP aligned, with your SOP applied
Case handling is aligned with ICH E2A, E2B(R3) and E2D and with GVP Module VI, and your own standard operating procedure is applied to every case. Each decision, whether made by an AI agent or by one of your experts, is recorded with who, when and why.
Standards applied
The rules every case is checked against.
- ICH E2A: definitions and seriousness
- ICH E2D: post-approval case management
- ICH E2B(R3): the electronic ICSR format
- GVP Module VI: collection and reporting
- MedDRA coding of reactions and history
- Your SOP applied to every case
Versioned SOPs
Controlled documents keep every version; a different person from the reviewer approves each one.
Your SOP, not ours
Your procedure decides what is checked, who signs off and what goes to an expert.
MedDRA coding
Reactions, indications and medical history are coded in MedDRA with your licensed dictionary version.
Validation documentation
Validation documentation for the platform is available on request.
FAQ
Pharmacovigilance services: frequently asked questions
What pharmacovigilance services does Edriza provide?
As a pharmacovigilance CRO, Edriza runs drug safety operations for pharmaceutical, biotech and generic companies: ICSR case processing, literature monitoring, aggregate reports (PSUR, PBRER, PADER, DSUR), signal management and regulatory submissions. The same work can also be run in house on the Edriza platform.
Can we outsource pharmacovigilance to Edriza?
Yes. You can outsource your PV work to our team, who run it on the Edriza platform under your SOP, or license the platform and run pharmacovigilance with your own team. Both use the same case flow and audit trail.
Does Edriza create E2B(R3) reports and submit them to regulatory authorities?
Yes. Each case is converted into an ICH E2B(R3) XML, checked against the E2B(R3) schema (XSD), submitted to the regulatory authority or partner, and the acknowledgement is tracked with the case.
How does literature monitoring work in Edriza?
Live Scan runs your search strategy per product against published literature such as PubMed/Medline, Local Journal covers the local journals you subscribe to, and Document Scan reads uploaded full texts. Every article is screened and recorded with its decision and reason, in line with GVP Module VI.
Who makes the decisions on a case?
Two independent AI agents process every case and a QC agent checks the result. Where they disagree, information is missing or your SOP asks for a person, the case goes to your experts. Every decision is recorded in the audit trail.
Is Edriza suitable for 21 CFR Part 11 and EU GMP Annex 11 environments?
The platform is built to support 21 CFR Part 11 and EU GMP Annex 11 requirements: audit trail, electronic signatures with re-authentication, access control and record versioning. Validation documentation is available on request.
Pharmacovigilance CRO services and platform, from one partner
Outsource your drug safety work to our pharmacovigilance team, or run it in house on the Edriza platform. Tell us about your products, sources and markets.
Contact
Contact us
Tell us about your products, sources and case volumes. We reply within 24–48 hours and, if you wish, show you the platform on your own data.
Email: info@edriza.com
Covered regions: India, EU, USA, UK, Canada, Japan, Middle East, Asia, Australia
Response time: 24–48 hours