Pharmacovigilance Consulting
with 20+ Years of Industry Contribution
Competency
Use of accelerators like regional guidance assessment to expedite business understanding of R3
regulations
Actively engaged with regulatory agencies to discuss improvements in guidance resulting in guidance updates
Detailed understanding on existing R3 guidance including EMA, FDA VAERS, FDA eMDR, FDA PMSR, PMDA R3, China R3, Korea R3 reporting requirements
Providing best practices and lessons learned on R3 implementation process enabling organizations to rollout R3 effectively
Proven experience of implementing R3 requirements for 30+ organizations
Solutions Implemented
30+ Organizations using Vitrana’s TransformPV and/or PVFilter
Integrations in production
with both
- EMA R3
- FDA VAERS
- FDA eMDR
- FDA PMSR
- PMDA (Japan)
- CDE (China)
- Korea R3
- EU MIR
Submissions to FDA, EMA, PMDA & CDA
Accomplishments
- Successfully helped organizations transition to R3 for EMA, PMDA, FDA eVAERS, FDA eMDR, FAERS+, Mexico, China, and Korea
- Successfully rolled out PMDA R3 profile updates for Cosmetics
- Implemented FDA R3 requirements for PM and IND
- Leading implementation of R3 requirements for LATAM at multiple organizations
- Deep understanding on R3 guidance including EMA, FDA ,PMDA, China & Korea R3 reporting requirements
- Vitrana brings best practices and lessons learnt on R3 implementation process enabling organizations to rollout R3 effectively
- Vitrana has published multiple whitepapers on compliance needs, process impact and technology changes required to meet the new regulatory needs (check Insights tabs)
Safety Database Implementation & Upgrades
Vitrana leverages a 5-stage implementation/upgrade methodology that has been prepared based on our experience implementing and upgrading 50+ Global and Japan environments at multiple pharmaceutical organizations.
Preparation Assesses project risks, business needs, and existing configurations and customizations.
Review existing system, understand the business needs
Blueprint Workshops, prototyping and final recommendations will drive decisions that finalize requirements and configuration in the next stage.
Business & IT workshops, Prototype / sandbox recommendations
Realization Approve, apply and remediate requirements & technical specifications, draft and dry run test scripts and upgrade process.
CRPs, finalize requirements & configurations and test dry runs
Transition Vitrana will coordinate closely with business on the three Ts: Testing, Training and Timing (Cutover).
System tests. UAT, Training and Cutover planning
Cut Over Production Go-Live, onsite support and extended, remote support, and environment decommissioning.
Execute production, System Upgrade and Hypercare
Vitrana is continually building on its projects successes. Several successful Safety Database upgrade projects have yielded many Vitrana assets in Argus and other safety databases
Data Migration
10+ successful migrations, 5000 to 5M+ records migrated, Industry-first capability framework for revisions and audit trail, Performance optimized- Our Migration Framework
- Three-Tiered Approach
- PL/SQL Framework - Standardized pre-migration checks, performance-tuned Minus Query validation, case revisions & audit trail migration
- E2B+ Methodology - Structured 5-phase process from requirements through production deployment
- Oracle/AWS Tools - Lift & shift, multi-tenant merge, cloud migration support
- Validation Strategy
- 100% automated SQL coverage of in-scope cases/fields
- E2B/Paper report comparison & balancing checks
- SME reviews and comprehensive UAT
- Migration Expertise
- Safety Systems: Argus Suite, ARISg, AERS, LSMV, Trace, Perceive, Legacy Systems
- Platforms: Oracle 9i-12c, SQL Server, Postgres, AWS/Azure DMS
- Experience: 20+ years leadership average, 310+ PV professionals, Global 24/7 support
Proprietary Accelerators (Up to 80% Reusability)
85+ anomaly scenarios, automated profiling & cleansing
Pre-validated field mappings, Minus Query framework, E2B comparison
ConfigManager for bulk loading, Gold CBD templates
IQ/OQ/PQ scripts, automated balancing, programmatic validation
Why Vitrana?
- Industry Experts - Former Oracle HSGBU architects who built Argus Safety Suite
- Regulatory Proven - MHRA, FDA, EMA, PMDA audit support experience
- Quality Assured - QMS audited by 30+ organizations, ISO-compliant processes
- Client Success - Direct engagement model, Consultative approach, 8-9 month typical delivery
PV reporting
Comprehensive Pharmacovigilance Reporting Solutions Across all Organization sizes | Enterprise Platforms | Custom Analytics Technology Stack- Enterprise Reporting Platforms: Cognos, OBIEE/OAS, JReport, Business Objects, Tableau
- Visualization & Search: PowerBI, Spotfire, Qlikview, Tableau, ElasticSearch, Kibana
- ETL Tools: Custom PL/SQL, Informatica, ODI
- Automation: Python scripting for automated reporting workflows
- Reporting Tool Implementation - Quality check with ready data warehouse and dashboards for QC.
- Late Log Analysis - Comprehensive reports and dashboards for compliance monitoring
- Global Compliance Reports - Multi-regional regulatory reporting solutions
- Custom Development - JReport and Spotfire report customization
- Operational Dashboards - Real-time tracking of reporting team activities and KPIs
- Aggregate Reporting - PSUR, PBRER, PADERs, and periodic safety reports
Why Vitrana Reporting?
Full-service reporting teams for enterprise clients
Expertise across all major BI and reporting tools
Japan-specific reporting and global compliance solutions
Tailored dashboards and reports for unique business needs
Built-in QC processes and validation frameworks
Transform your PV reporting with Vitrana's proven expertise and technology solutions.
Project Management
Monitors Project status and reports to Steering Committee, for furtherance to senior leadership and other stakeholders
Monitors and escalates key issues and risks to Steering Committee and advises for Go/No-Go decisions
Oversees Project teams to ensure execution against defined Project scope, timeline, cost & quality standards
Key Project milestones and tracking through Governance model
Implements and maintains Project performance measures
Financial Management, Budgetary control and variance reporting
Engagement, SOWs, On-boarding, performance feedback
Hosting & Managed Services
- Available – as desired, Emphasis on delivering an experience of collaboration, matched by dedicated service goals
- Committed to client data security and management
- SLA adherence and PV compliance as never heard before in the industry
- Backed up a team that is innovative, PV and Argus experienced and resourceful with leading tools and technology
- Well documented process framework established for AMS support available and in practice
- Well documented process framework established for AMS support available and in practice
- Ticket Categories (Change Requests, Incidents, Access Requests)
- Ticket Priority definition and Management
- Communication Process with response templates
- System Support Plan/SOP
- Ticket Follow-up, Defect Closure
- Consistent touchpoint managing all client transactions and communications
- Release Management
- Adherence to client’s quality system
- Oversees Client training execution and SOP adherence of support team
- Participation and support in Audits/Inspections
Vitrana Cloud Differentiators
- Best in class, innovative & fully customized hosting platform.
- A Single-Tenant environment with no constraints on scale & integration configurations.
- Option to have single or individual contracts for application services and hosting. Flexibility to partner with any number of Service Providers.
- Switch on & Switch off VM’s at will, add processing power to the network at ease with no network down time.
- Full access and control of your environment and applications. Client will always have the option of administrative access on hosted Applications.
- Just in Time ramp up and ramp down options to match to your evolving business needs.
- Option to scale and integrate with all Lifesciences IT landscape future needs.
Vitrana Japan Services Overview
- PMDA R3 Submissions (10+ Japan based organizations)
- PMDA R3 Cosmetics reports (first in industry)
- PMDA Device Reporting
- China R3, Korea R3, and Taiwan R3 Submissions
- Listing for their Safety database using various reporting and Visualization tools including Cognos, OBIEE, Tableau, Spotfire, J Reports, PowerBI
- Reports generated on both Transactional and DLP database
- Merging of Japan processes to global safety database
- Included Data migration of Japan cases to global database
- Data Migration for Product Acquisition / Divestures / Mergers
- Argus J Implementation
- Argus / Argus J Upgrades
- Japan Configuration Support
- Safety System Infrastructure Services
- WHO CRT loading in Safety System
- Bi-lingual PV (Pharmacovigilance) Experts
- Multiple Japan customers
- Seamless integration with Safety Helpdesk Services
Strategic Implementation, Customizations, Upgrades, Migration, and Managed Services by a Team led by the pioneers who built Argus Safety
Partner with the industry's most experienced safety consulting team, led by former Oracle engineers and architects who designed Argus Safety. Our 300+ specialists deliver end-to-end pharmacovigilance solutions including complex database migrations (4M+ cases successfully migrated), system implementations, regulatory compliance, and 24/7 managed services.
With proven expertise across FDA, EMA, PMDA, and other regulatory authorities, we've achieved 99% SLA performance and zero regulatory escalations for our clients. From lift-and-shift cloud migrations to comprehensive validation and ongoing support, Vitrana transforms your PV operations while ensuring business continuity.
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