Case Intake and Duplicate Detection
Case intake spans spontaneous reports, literature, clinical trials, and patient programs, with duplicate detection preventing the same event entering as multiple cases.
Custom Software
Pharma Pharmacovigilance Platform Development
Pharmacovigilance platforms manage the full safety case lifecycle from intake through regulatory submission: ICSR processing, MedDRA coding, causality documentation, E2B transmission to health authorities, signal management, and periodic report production. Medical judgment stays with qualified safety personnel throughout, and no submission is transmitted without their approval.
Pharmacovigilance systems are inspected, and their records are legal evidence of how a sponsor met its safety obligations. Taction Software builds pharma pharmacovigilance platform capability where validation, audit trails, and submission integrity are engineering deliverables. Where the need is machine learning on top of an existing safety database, our adverse event detection work covers that layer separately.
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What Is a Pharmacovigilance Platform
A pharma pharmacovigilance platform manages individual case safety reports from receipt through submission and follow-up, alongside signal management and periodic reporting obligations. Core capability includes multi-source intake, duplicate detection, MedDRA coding, seriousness and expectedness assessment workflow, narrative authoring, E2B formatted transmission to FAERS and EudraVigilance, and production of periodic reports. Our work sits within our broader pharma and life sciences practice.
MedDRA Coding Workflow
MedDRA coding applies the terminology dictionary under license from the maintenance organization, with coding decisions confirmed by trained personnel.
Case Assessment Workflow
Seriousness and expectedness assessment routes to qualified reviewers, since these determinations drive reporting timelines and require medical judgment.
E2B Regulatory Submission
E2B R3 transmission formats cases for FAERS, EudraVigilance, and other authorities, with submission occurring only after qualified approval.
Signal Management
Signal management tracks detection through evaluation and action, maintaining the documented decision trail inspections examine closely.
Periodic Report Production
PSUR and PBRER production assembles case data and cumulative analyses, with medical writing and interpretation performed by your safety team.
Core Pharmacovigilance Platform Services
Our pharma pharmacovigilance services cover safety database development, intake automation, submission gateway integration, signal workflow, periodic reporting, and validated delivery. Most engagements are extensions or integrations rather than full database replacement, since established safety databases handle core case management well and replacing them is rarely justified. We assess that honestly. Engagements typically open with a review of case volume, current system constraints, and inspection history.
01
Safety Database Development
Where custom capability is warranted, we build case management with the data model, audit trails, and workflow safety operations require.
02
Intake Automation
Intake automation processes structured and unstructured sources, drawing on our clinical NLP development practice for narrative extraction.
03
Submission Gateway Integration
Gateway integration handles E2B transmission and acknowledgment processing, since submission failures must be detected rather than assumed successful.
04
Signal Detection Analytics
Signal work connects with our pharma clinical AI capabilities, applying disproportionality methods with underlying cases always accessible.
05
Literature and Data Source Monitoring
Literature and real world sources extend surveillance, connecting with real world evidence platform work for post-market data.
06
Part 11 Validated Delivery
Safety systems require validation. Our 21 CFR Part 11 for AI work covers audit trails, signatures, and computer system validation.
Benefits of a Purpose-Built Pharmacovigilance Platform
The benefits concentrate in case processing throughput, submission reliability, and inspection readiness. Safety operations scale poorly because case volume grows with product exposure while headcount does not, and much of the work is structured processing rather than medical judgment. We publish no figures on processing time, compliance rates, or case throughput, because those depend entirely on product portfolio, case mix, and current process maturity.
Increased Processing Capacity
Automating case processing steps reallocates qualified reviewer time toward assessment, which is the work only they can perform.
Reliable Submission Handling
Acknowledgment processing confirms transmissions succeeded, since undetected submission failures create compliance exposure that surfaces during inspection.
Reduced Duplicate Burden
Duplicate detection across intake sources prevents the same event consuming reviewer capacity multiple times under different case numbers.
Documented Signal Decisions
Complete signal trails from detection through evaluation and action provide the documented reasoning inspections consistently examine.
Faster Periodic Reporting
Automated data assembly shortens PSUR preparation, leaving medical writing and interpretation to safety physicians rather than data collection.
Inspection Readiness
Complete audit trails and validation evidence support inspection as a maintained state rather than a pre-audit assembly project.
Our Pharmacovigilance Platform Process
We deliver pharma pharmacovigilance projects in gated phases so safety, quality, and IT stakeholders approve direction before engineering cost accumulates. Discovery establishes case volume, current system constraints, validation scope, and whether extension serves better than replacement. Validation planning precedes development. Submission integrity receives particular attention, since a case that appears transmitted but was rejected creates a compliance gap that may go unnoticed until inspection.
Discovery and System Assessment
Discovery evaluates whether extension or integration serves better than replacement, since established safety databases handle core case management well.
Validation Scope Definition
Validation requirements are scoped with quality assurance before development, since GxP obligations materially affect architecture, timeline, and cost.
Data Model and Migration Planning
Where migration is involved, data integrity planning is critical, since historical cases must remain complete and attributable after transfer.
Development and Integration
Development proceeds with traceability maintained from requirement through test, accumulating validation evidence rather than producing it afterward.
Submission Testing
E2B transmission is tested end to end including acknowledgment and negative acknowledgment handling, since silent failures are the dangerous case.
Validated Deployment and Support
Deployment follows IQ, OQ, PQ protocols with documented evidence, followed by change control and revalidation as regulations and terminology change.
Technology and Compliance
Pharmacovigilance systems operate under 21 CFR Part 11, GVP requirements in the EU including pharmacovigilance system master file obligations, and regional reporting rules with differing timelines and formats. MedDRA use requires a subscription from the maintenance organization, which is a separate licensing cost. Taction holds ISO 27001 certification. The requirement deserving emphasis is submission integrity: a case believed transmitted but actually rejected creates a reporting failure that typically surfaces during inspection rather than at the time.
21 CFR Part 11 Compliance
Part 11 requires audit trails, electronic signatures, and computer system validation, shaping architecture from initial design decisions.
E2B and Regional Formats
E2B R3 and regional variations differ in required fields and validation rules, so submission handling is built per authority rather than generically.
MedDRA Licensing
MedDRA requires subscription from the maintenance organization. Licensing is separate from engineering cost and version updates are managed as releases.
Submission Acknowledgment Handling
Acknowledgment processing detects rejections explicitly, since undetected submission failure produces a reporting gap discovered during inspection.
Data Integrity Principles
ALCOA expectations govern how records are created, changed, and retained, which affects edit handling and version management technically.
Deployment Security
Deployments run in your cloud tenancy or hybrid, with network segmentation, signed container images, and documented penetration testing before release.
Why Choose Taction Software
Taction Software was founded in 2013 and has spent over 12 years building healthcare and life sciences software, delivering more than 200 healthcare projects from four US offices in Chicago, Cheyenne, Austin, and Sacramento, with ISO 27001 certification. Our relevant judgment here is recommending extension over replacement in most cases. Established safety databases handle core case management well, and replacing one is a large, risky project rarely justified by the problems clients actually describe. Our leadership brings more than 20 years of personal experience in the field.
01
Extension Over Replacement
We assess whether extending your existing safety database serves better than replacing it, which it usually does given migration risk.
02
Submission Integrity Focus
We build acknowledgment handling explicitly, since silent submission failures are the compliance gap most likely to surface during inspection.
03
Validated System Delivery
We produce Part 11 validation evidence as a work product rather than assembling documentation retrospectively before an audit.
04
Established Healthcare Focus
Founded in 2013, we have concentrated on healthcare and life sciences rather than treating them as one vertical among several.
05
Clinical Language Experience
Our clinical NLP work handles medical narrative structure, which general-purpose extraction handles poorly in safety case contexts.
06
Certified Security Posture
ISO 27001 certification means security controls are documented and auditable, supporting sponsor and inspection readiness efficiently.
Pricing
Pharma pharmacovigilance pricing depends on scope, whether you are extending or replacing, case volume, submission regions, and validation depth. Extension and integration engagements cost considerably less than full platform replacement, and we recommend them where they fit. Validation is a substantial component for GxP systems and is scoped separately. Discovery produces an itemized, fixed-scope estimate with phase-level breakdown. MedDRA licensing, gateway fees, and cloud infrastructure are separate from engineering.
MVP or Single Module
An MVP covering intake automation or submission gateway integration typically runs $40,000 to $80,000 with proportionate validation.
Full Platform Build
A full platform with case management, coding workflow, submission, and signal management typically falls between $80,000 and $200,000.
Enterprise Deployment
Enterprise engagements covering multi-region submission, portfolio scale, full validation, and migration start at $200,000.
Discovery and Validation Planning
Discovery is a paid, time-boxed phase producing an itemized estimate, architecture plan, and validation scope reviewed with quality assurance.
Cost Drivers to Expect
Validation scope, submission regions, migration complexity, and case volume are the largest variables, identified during discovery for budget planning.
Ongoing Support Costs
Post-launch revalidation, MedDRA version updates, regulatory format changes, and support are quoted separately as a retainer sized to case volume.
Get Started
If you are evaluating pharma pharmacovigilance platform work for case management, submission integration, signal workflow, or periodic reporting, the fastest next step is a discovery call with our team. We will assess whether extension serves better than replacement, scope validation with your quality function, and return an itemized, fixed-scope estimate. Contact us to schedule that conversation.
FAQs
Frequently Asked Questions
Safety and quality leaders evaluating pharma pharmacovigilance platform work usually ask whether replacement is justified, how submission failures are caught, and what validation costs. The answers below reflect how we scope these projects.
Usually not. Established safety databases handle core case management well, and replacement involves migration risk to historical records that must remain complete and attributable. Most problems clients describe are addressable through extension, integration, or automation layered onto the existing system.
Through explicit acknowledgment and negative acknowledgment processing, with failures raised as actionable exceptions rather than logged silently. A case believed transmitted but actually rejected creates a reporting gap that typically surfaces during inspection, which is the worst possible time to discover it.
Yes. MedDRA requires a subscription from the maintenance organization, charged separately from engineering cost. Version updates are released periodically and are managed as controlled changes, since recoding implications affect historical case data and require deliberate handling.
An MVP covering intake or submission integration runs $40,000 to $80,000. A full platform typically falls between $80,000 and $200,000. Enterprise multi-region deployments with migration start at $200,000. MedDRA licensing and gateway fees are separate.
It can extract case elements and propose triage classification, which reallocates reviewer time meaningfully. It cannot perform causality assessment, which requires medical judgment. Any generated narrative text requires human review, since fabricated detail in a safety record is a regulatory problem rather than a quality issue.
Detection AI is a layer applied to safety data for extraction, triage, and signal surfacing. A pharmacovigilance platform is the system of record managing cases through submission and periodic reporting. Many organizations already have the platform and need the layer, which we scope separately.