Accessible reporting
Citizens can report a suspected reaction in clear language without navigating a complex regulatory form.
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ODA · PHARMACOVIGILANCE & AERS
ODA
Every report matters.Every case deserves follow-through.
ODA gives citizens and healthcare professionals a simple way to report suspected adverse events after medicine use, then gives pharmacovigilance teams the structured case-management tools needed to review, investigate, follow up and act.
Citizen reportingProfessional reviewICSR-ready modelSafety alertsInternational interoperability
ODA SAFETY DESK
National safety picture
128
+18%
New reports
43
34%
In medical review
17
13%
Follow-up required
06
watch
Safety signals
Case pipelineLIVE
Intake78%
Validated61%
Medical review43%
Ready for decision29%
FROM PUBLIC REPORTING TO REGULATORY ACTION
A complete pharmacovigilance workflow, not just a web form.
Reporting is only the first step. ODA is designed to transform an initial citizen or professional declaration into a structured pharmacovigilance case that can be triaged, reviewed, enriched, monitored and prepared for exchange with national or international safety ecosystems.
Clinical review
Authorized pharmacovigilance professionals receive a structured case file for medical assessment and follow-up.
Case lifecycle
Move each report through controlled statuses, assignments, observations, follow-up and closure.
Global awareness
Bring external safety notices and international pharmacovigilance information into the national operational picture.
CITIZEN & PROFESSIONAL REPORTING
Make adverse-event reporting understandable and reachable.
A person who experiences an unexpected health problem after taking a medicine should be able to report what happened without needing to understand pharmacovigilance terminology. ODA separates the simple reporting experience from the deeper professional case record.
01
Tell us what happened
Describe the symptoms or health problem in everyday language.
02
Identify the medicine
Capture the suspected medicine, product information and when it was taken.
03
Describe timing & outcome
Record when the event started, its evolution and whether care was required.
04
Add useful context
Provide relevant medical context and supporting documents when available.
05
Submit securely
Create a traceable report for the national pharmacovigilance team.
ODA is a reporting and pharmacovigilance platform. It does not replace medical consultation or emergency care.
BACK-OFFICE CASE MANAGEMENT
From incoming declaration to professionally managed safety case.
The back office gives pharmacovigilance professionals a shared workspace for triage, data quality, clinical review, follow-up, seriousness assessment, observations, decisions and regulatory traceability.
Unified case inbox
Centralize citizen, healthcare-professional and imported reports into a single operational queue.
Triage & validation
Check minimum information, duplicates, completeness and priority before deeper review.
Medical assessment
Support structured professional assessment, narrative review and expert observations.
Seriousness & priority
Flag cases requiring accelerated review, follow-up or regulatory attention.
Follow-up
Request and capture additional information while preserving the history of the case.
Assignment & collaboration
Assign cases to reviewers, supervisors or specialized teams with clear ownership.
Case history
Preserve status changes, comments, timestamps and reviewer activity for traceability.
Controlled closure
Close cases with a documented outcome while keeping them available for analysis and exchange.
CASE LIFECYCLE
A controlled process from signal intake to closure.
REPORT
Declaration
TRIAGE
Validation
REVIEW
Medical review
FOLLOW-UP
Enrichment
DECISION
Assessment
EXCHANGE
Regulatory exchange
CLOSE
Closure
STRUCTURED SAFETY DATA
Build the case once. Reuse it across surveillance, analysis and reporting.
ODA is designed around the Individual Case Safety Report (ICSR) concept so information collected from the public can progressively become structured regulatory-grade safety data.
Patient / subject
Demographics
Relevant history
Outcome
Reporter relationship
Suspected product
Medicine
Dose / route
Dates
Indication
Concomitant products
Adverse event
Reported reaction
Onset
Seriousness
Evolution
Medical attention
Case context
Narrative
Documents
Follow-up
Reviewer observations
Audit history
INTERNATIONAL PHARMACOVIGILANCE ECOSYSTEM
Designed to connect national safety surveillance with the world.
ODA's integration layer can be adapted to approved regulatory channels, public safety feeds and national-authority agreements. Access rules differ by ecosystem, so the platform treats these as governed integrations rather than assuming every database is an open API.
National PV Hub
WHO PIDM / VigiBaseUMC VigiFlowEMA EudraVigilanceFDA AEMS / FAERSWHO Medical Product Alerts
WHO PIDM / VigiBase
Global ICSR ecosystemSupport a national pharmacovigilance programme's pathway toward structured case exchange with the WHO global safety database through the appropriate national/UMC mechanisms.
UMC VigiFlow
National PV case workflowInteroperate with workflows used by national pharmacovigilance centres and prepare compatible ICSR information for governed exchange.
EMA EudraVigilance
European safety exchangePrepare for ICSR exchange and safety-signal workflows required in European pharmacovigilance contexts.
FDA AEMS / FAERS
US adverse-event ecosystemConsume public safety data or prepare standards-based exchange patterns where permitted, while tracking FDA safety signals and notices.
WHO Medical Product Alerts
Global safety alertsBring published WHO medical-product alerts into the national monitoring workspace for awareness and escalation.
WHO-READY BY DESIGN
Interoperability starts with the right data model and terminology.
ODA is designed to align with the structures used in international pharmacovigilance. 'WHO-ready' describes the architectural objective; it is not presented as a WHO certification or endorsement.
ICH E2B(R3)
Structure ICSR data for modern electronic regulatory exchange and future database-to-database interoperability.
MedDRA
Code adverse events and medical concepts using the internationally used regulatory medical terminology.
WHODrug
Support standardized medicinal-product coding when the organization holds the required UMC subscription/licence.
ICSR data model
Preserve structured patient, reporter, product, reaction, seriousness, narrative and follow-up information.
Governed exchange
Keep external submission and data-sharing behind configurable authorization, validation and audit controls.
Local + international
Retain local fields and workflows while mapping the information required by international exchange standards.
SAFETY INTELLIGENCE
Bring external alerts and local cases into one safety picture.
National teams should not have to monitor every international portal manually. ODA can centralize imported notices, regulator publications and local case trends so reviewers can identify what deserves attention.
External alert feeds
Ingest approved public alerts and safety notices from selected international or regional sources.
Local case trends
Monitor volumes, products, reactions, geography and case status across the national database.
Priority watchlists
Highlight medicines, events or alerts that require focused review by the pharmacovigilance team.
Internal dissemination
Route relevant alerts to authorized reviewers, programmes or decision-makers without relying on ad-hoc forwarding.
ONE NATIONAL PLATFORM · MULTIPLE ACTORS
Built for citizens, professionals and regulators.
Citizens & patients
Simple reporting experience, clear language and traceable submission.
Healthcare professionals
Professional reporting and structured follow-up on clinically relevant information.
National regulatory authorities
Centralized case supervision, assignment, quality control, analytics and regulatory exchange.
Pharmacovigilance centres
Collaborative review, data quality, signal awareness and operational dashboards.
DEPLOYMENT MODEL
A national pharmacovigilance platform should fit the health system around it.
Public citizen-reporting portal
Professional / authenticated reporting portal
Pharmacovigilance case-management back office
Role-based review and supervision
International integration adapters
Dashboards, audit logs and safety intelligence
Configurable local workflows and terminology
Private or sovereign deployment options
ODA
Make it easier to report. Make every report easier to act on.
Talk to ALIBORA about your national pharmacovigilance workflow, reporting channels, regulatory roles, data standards and international exchange requirements. ODA can be configured around the operating model of the authority or programme.