Pharmacovigilance From Case Intake to Regulatory Submission
Manage safety data across clinical trials and post-approval pharmacovigilance in one configurable platform – from intake and triage to medical review, reporting and submission.
E2B(R3)
gateway submissions
3-10wks
to go live
15+
years supporting PV operations
21 CFR 11
validated
A Tuesday, before vs. after
An SAE arrives by email and gets retyped into the safety databaseIntake, triage and case processing run in one configurable workflow
Submissions tracked in a spreadsheet, per country, by handA multi-country tracker shows what is submitted, due or overdue
Every case narrative written from scratch by a medical reviewerNarratives are generated from configurable templates for reviewer edit and approval
Designed to Support Regulated Pharmacovigilance Operations
Core controls such as audit trails, role-based access, electronic signatures, versioning, and validation documentation are included as standard. The platform supports ICH E2B(R3), GVP, 21 CFR Part 11, GDPR and applicable regional PV requirements.
"Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices."
Tameo Kobayashi
Chief Innovation Officer, CMIC Holdings
"I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done."
Craig Winter
CIO, Agenus Inc.
After evaluating multiple solutions, Flex Databases stood out as the best fit for our company. Its system offers the ideal balance between simplicity, flexibility, and competitive pricing.
Santiago Figueroa Perez
Chief Operating Officer
Flex Databases meet the regulatory requirements and provide customization services with impressive flexibility within a reasonable budget.
Jessica Chang
Senior Director, A2TW Clinical Operations Department
A Serious Adverse Event Shouldn’t Need Five Tools to Reach Out to the Regulator
Flex Pharmacovigilance replaces the email inboxes, spreadsheets, and safety tools with one controlled workflow from the initial report through case processing, submission, and authority acknowledgement.
Three Recurring PV Problems, Addressed
These map to what the platform actually does day to day — not abstract feature names.
Cases retyped between intake forms, the database and submission tools
Safety Case Processing
One configurable workflow covers intake, triage, data entry, coding, medical review, QA, reporting, and archiving – with duplicate search, validity checks and narratives generated from configurable templates.
Submission deadlines tracked manually, per country, in a spreadsheet
Reporting & Regulatory Submissions
Configurable rules and schedules support expedited and periodic reporting to EudraVigilance, FDA FAERS and partners – with CIOMS and MedWatch forms, a periodic report constructor, and a multi-country submission tracker.
Signals found too late in a statistician’s separate systems and reports
Signal Detection & Risk Management
Quantitative and qualitative signal workflows are available in the system – including disproportionality methods such as MGPS and EBGM, structured validation, prioritization, assessment and case-series generation.
Every Part of the PV System, in Plain Terms
Everything a safety team needs from first report to authority acknowledgement — each area validated independently and connected by default, so nothing has to be stitched together later.
Case Processing Workflow
Manage intake, triage, data entry, coding, medical review, QA, reporting, and archiving in one configurable workflow aligned with your SOPs.
Automatic duplicate search on configurable criteria
Automatic validity checks before a case moves forward
Query management on any case field, with a tracked question-and-response history
Narrative generation from configurable templates for reviewer edit and approval
Case versioning for follow-ups and amendments, full history
Data Exchange & Dictionaries
Exchange ICSRs in the formats used by authorities and partners, with dictionary coding and version management available in the same system.
E2B(R3) and R2 XML import/export, manual and automatic
Built-in MedDRA and WHODrug coding, including assisted workflows
Dictionary version management keeps historical cases consistent
Export to Excel, Word, XML and PDF for QC and sharing
Multilingual input for global case sources
Regulatory Submissions
Manage destination-specific reporting rules and schedules, then submit through configured EDI gateways
Direct EDI gateway connections to authorities and partners
CIOMS I and MedWatch 3500A/3500 forms, plus local forms
Full audit trail for submissions, acknowledgements, corrections
Configurable reporting rules and schedules per destination
Multi-country submission tracker: submitted, due, overdue
Periodic Reports & Analysis
Build PSUR, PBRER and DSUR line listings and tabulations from data already held in the system, reducing manual report assembly.
Periodic report constructor: line listings, cumulative and summary tabulations
Configurable PSUR, PBRER and DSUR line listings
Report calendar to manage periodic report timelines
Ad hoc reporting for additional operational questions
Signal Detection & Management
Review quantitative and qualitative signal information in dashboards using current case data.
Quantitative methods including statistical, machine-learning and neural-network approaches
MGPS and EBGM scores to support review of product–event combinations
Qualitative detection through structured medical review
Signal validation, prioritization and assessment workflow
Case series generation as supporting evidence
Implementation, Migration & Support
Implementation covers system configuration, gateway setup, validation documentation and planned migration of historical safety data.
Implementation including workflow configuration, gateway setup, and validation documentation
Planned migration from legacy PV systems with data mapping, reconciliation and verification
Training and ongoing support for safety operations, medical reviewers, QPPVs and affiliates
Notifications and alerts on actions due and upcoming deadlines
Why Flex Pharmacovigilance?
We have built robust regulated safety software since 2011. Flex Pharmacovigilance brings that experience to drug PV, medical-device vigilance and vaccine safety. More than 100 teams in 30+ countries use Flex, with support in North America and Europe.
Multiple safety tools stop at the case entry stage – submissions still happen somewhere else
End-to-end PV in one system
Case intake, case processing, quality checks, submissions, follow-ups and signal management run on a single platform instead of scattered tools.
Keeping pace with each authority’s E2B requirements is a manual chore
Supports global E2B(R3) reporting
Configured gateways and E2B(R3) import and export support reporting to EudraVigilance, FDA FAERS and other destinations according to defined rules and schedules.
Growing case volumes usually mean growing headcount, linearly
Designed for high case volumes
Automation, configurable workflows and duplicate checks reduce repetitive work and help teams manage higher case volumes without proportionate growth in manual processing.
Narratives steal medical reviewer hours, case after case
Auto-narratives, reviewers in control
Case narratives are generated from configurable templates for medical reviewers to edit and approve.
Signal detection lives in a statistician’s separate systems and reports
Signal detection built in
Available methods include MGPS and EBGM, statistical and machine-learning approaches, and structured qualitative review within the same system as the cases.
Drugs, devices and vaccines often mean three separate safety systems
One platform for drugs, devices and vaccines
Drug pharmacovigilance, medical-device vigilance and vaccine safety are supported within one controlled environment, with shared audit and workflow controls.
A standalone safety database means re-entry of every SAE from the EDC
One platform with EDC, CTMS and eTMF
PV shares a platform with EDC, CTMS and eTMF. SAE data can flow from EDC into the safety database and MVRs without re-entry.
Enterprise-grade usually comes with an enterprise-grade invoice
Enterprise capability, sensible cost
Enterprise-grade pharmacovigilance capabilities without enterprise-suite complexity or cost. You pay for the modules you use.
Weeks of vendor training before a case processor is productive
Intuitive from day one, with people behind it
Case processors can begin working within days after role-specific onboarding, with product specialists available throughout implementation and ongoing use.
Time to implement
Email & spreadsheets
Immediate, but nothing is compliant
Flex PV
3–10 weeks, gateway included
Legacy enterprise safety DB
6–18 months
E2B(R3) submissions
Email & spreadsheets
Not possible
Flex PV
Direct gateway, automated rules
Legacy enterprise safety DB
Present, configuration-heavy
Signal detection
Email & spreadsheets
Manual review only
Flex PV
MGPS, EBGM, ML — built in
Legacy enterprise safety DB
Separate module, separately priced
Changing the case workflow
Email & spreadsheets
Ad hoc, undocumented
Flex PV
Configured by your own team, per your SOPs
Legacy enterprise safety DB
Change request to the vendor
Connection to EDC & eTMF
Email & spreadsheets
Retype everything
Flex PV
Same platform, no re-entry
Legacy enterprise safety DB
Integration project per system
| Email & spreadsheets | Flex PV | Legacy enterprise safety DB | |
|---|---|---|---|
| Time to implement | Immediate, but nothing is compliant | 3–10 weeks, gateway included | 6–18 months |
| E2B(R3) submissions | Not possible | Direct gateway, automated rules | Present, configuration-heavy |
| Signal detection | Manual review only | MGPS, EBGM, ML — built in | Separate module, separately priced |
| Changing the case workflow | Ad hoc, undocumented | Configured by your own team, per your SOPs | Change request to the vendor |
| Connection to EDC & eTMF | Retype everything | Same platform, no re-entry | Integration project per system |
One Platform That Grows With Your Needs
Add products, countries and thousands of cases a year, and it's still the same login, the same workflows, the same platform — no migration project waiting at the other end of growth.
Your whole safety portfolio
Manage drugs, devices and vaccines across studies and markets, with tenant-based segregation and role-based access for CROs serving multiple sponsors.
Connects to what you already run
Flex Pharmacovigilance supports integration with all major EDC systems, clinical databases, partner gateways and reporting tools, helping safety data move between established systems.
Access built around your org chart
Case processors, medical reviewers, QPPVs, affiliates and external partners each see exactly what their role needs – configurable, role-based, fully audited.
Onboarding that scales with your team
A named implementation lead guides a typical initial setup in 3–10 weeks, including workflow and gateway configuration. Legacy migration timelines depend on data volume, complexity and reconciliation requirements.
Fits Into Your Existing Stack
Keep established systems where needed while Flex PV supports controlled safety-data exchange between them.
Integration with established systems
Flex PV supports common clinical, safety and reporting interfaces, with other integrations assessed during implementation.
- EDC and clinical databases – connected SAE data flows can reduce re-entry
- Data export to Excel, Word, XML and PDF
- EDI gateways with authorities and partners
- Every other Flex module, on the same data model
- E2B(R3) and R2 XML import/export
Accessible Anywhere, With a Typical 3–10 Week Initial Setup
Cloud by default, on-premise if your policy requires it — either way, your team just opens a browser and works. No client software to manage, no manual updates to schedule.
HOSTING
Cloud or on-premise, your choice
ACCESS
Any browser, any device — plus a mobile app
SUPPORT
Named implementation lead
Setup
Typical initial setup in 3–10 weeks, including gateway configuration
3–10
weeks from kickoff to go-live
Common PV Problems That Slow Down Safety Operations
hese issues add avoidable work to case processing, submissions and signal review. Each maps to a workflow supported in Flex Pharmacovigilance.
The same case gets typed into three systems
Intake form, safety database, submission tool — each one a chance for the versions to drift apart, and each re-entry a data quality risk nobody has time to reconcile.
Submission deadlines live in a spreadsheet
Someone maintains a country-by-country tracker by hand. When they're on leave, the team finds out what's overdue from the authority, not from the tracker.
Duplicates slip through and skew the data
The same event arrives from two sources under different names, gets processed twice and affects downstream reporting until reconciliation or review identifies it.
Dictionary updates break historical consistency
A new MedDRA version can leave historical and current cases coded against different dictionaries unless the version used for each case is recorded and controlled.
Signals are found retrospectively
When disproportionality analysis runs periodically in a separate toolkit, product–event combinations may reach medical review later than intended.
Recognize more than two of these?
That's usually the point where a unified PV system pays for itself before the next inspection.
How Flex Pharmacovigilance Fixes Different Problems
Each problem above maps directly to something the platform does differently — not a feature list, a fix.
The Problem
Cases retyped between intake, database and submission tools
What Flex does about it
One workflow from intake to submission — entered once, used everywhere
The Problem
Submission deadlines tracked by hand per country
What Flex does about it
Multi-country tracker with configurable rules — due and overdue at a glance
The Problem
Duplicate cases double-counting in reports
What Flex does about it
Duplicate search on configurable criteria during intake and case processing
The Problem
Dictionary updates breaking historical consistency
What Flex does about it
Version management keeps each case tied to the MedDRA version it was coded in
The Problem
Signals found quarterly, in retrospect
What Flex does about it
MGPS, EBGM and ML-assisted methods available in dashboards using current case data
| The Problem | What Flex does about it |
|---|---|
| Cases retyped between intake, database and submission tools | One workflow from intake to submission — entered once, used everywhere |
| Submission deadlines tracked by hand per country | Multi-country tracker with configurable rules — due and overdue at a glance |
| Duplicate cases double-counting in reports | Duplicate search on configurable criteria during intake and case processing |
| Dictionary updates breaking historical consistency | Version management keeps each case tied to the MedDRA version it was coded in |
| Signals found quarterly, in retrospect | MGPS, EBGM and ML-assisted methods available in dashboards using current case data |
What Actually Changes in Week One With Flex PV
A practical comparison with common safety-database workflows.
| Task | Typical safety database | Flex Pharmacovigilance |
|---|---|---|
| Getting a new case processor productive | Formal vendor training, weeks to proficiency | Video tutorials available in the system leading to conquering case processing within hours |
| Adding a new reporting destination | Change request, vendor timeline | Configured by authorized administrators under change control |
| Building a PSUR line listing | Professional services quote required | Built with the report constructor |
| Upgrading to a new MedDRA version | A migration mini-project | Managed in-system, history preserved |
| Getting a straight answer from support | Ticket queue, SLA measured in days | Named product and support contacts |
Task
Getting a new case processor productive
Typical safety database
Formal vendor training, weeks to proficiency
Flex Pharmacovigilance
Video tutorials available in the system leading to conquering case processing within hours
Task
Adding a new reporting destination
Typical safety database
Change request, vendor timeline
Flex Pharmacovigilance
Configured by authorized administrators under change control
Task
Building a PSUR line listing
Typical safety database
Professional services quote required
Flex Pharmacovigilance
Built with the report constructor
Task
Upgrading to a new MedDRA version
Typical safety database
A migration mini-project
Flex Pharmacovigilance
Managed in-system, history preserved
Task
Getting a straight answer from support
Typical safety database
Ticket queue, SLA measured in days
Flex Pharmacovigilance
Named product and support contacts
Why This PV Software Fits Every Type of Team
One configurable core, not a different product per segment — each team gets what it actually needs from it.
CROs
Multi-tenant access lets one PV team serve multiple sponsors, with data segregated by tenant, sponsor, and role, and workflows configured to each client’s SOPs.
Sponsors
Manage clinical-trial safety and post-approval pharmacovigilance in one database, supporting a continuous product safety record across the lifecycle.
Academic & research institutions
Investigator-initiated trials can use controlled case processing and E2B(R3) submission workflows in a deployment sized to the program’s scope.
15+
Years of operations
500+
Companies using Flex Databases
45,000+
Users across the globe
100+
Clients
20,000+
Daily active users
10m+
Documents
2,000+
Clinical trials
40+
Countries
Pharmacovigilance Software: Frequently Asked Questions
Talk to us. See it yourself
Skip the generic demo. A specialist who works with this platform every day will walk you through it live, answer the hard questions directly, and show you exactly how it would run in your organization — not a script, not a slide deck.