Pharmacovigilance Technology Consulting

Strategic and technical consulting for organizations implementing, managing, or modernizing enterprise pharmacovigilance platforms, with a focus on Oracle Argus Safety.

System Implementation & Modernization
Planning and execution support for new implementations, upgrades, platform migrations, and system modernization initiatives.

Solution Architecture & Configuration
Designing system architecture, workflows, reporting rules, business configurations, and operational processes aligned with organizational requirements.

Performance & Operational Optimization
Identifying system bottlenecks, addressing performance challenges, and improving platform stability and operational efficiency.

Enterprise System Integration
Designing and implementing integrations between safety platforms, clinical systems, regulatory gateways, data warehouses, and other enterprise applications.

Helping organizations establish reliable, scalable, and compliant data ecosystems across their pharmacovigilance technology landscape.

Safety Data Migration
Planning and managing complex migrations from legacy safety databases to modern pharmacovigilance platforms, ensuring data completeness, accuracy, and traceability.

E2B Regulatory Reporting & Integration
Implementation, configuration, and troubleshooting of E2B(R2)/E2B(R3) interfaces and electronic regulatory data exchange.

Data Quality & Integrity Management
Defining data validation, reconciliation, and quality assurance approaches to maintain data integrity throughout migration and system integration initiatives.

Integration Architecture & Strategy
Evaluating existing system landscapes and designing scalable integration architectures to support seamless data exchange across enterprise applications.

Supporting organizations in establishing compliant, validated, and well-governed pharmacovigilance technology environments throughout the system lifecycle.

Computerized System Validation (CSV)
Validation strategy, planning, and documentation support, including requirements specifications, risk assessments, IQ, OQ, PQ, and traceability matrices.

Regulatory Compliance & Data Integrity
Technology alignment with applicable regulatory requirements, including 21 CFR Part 11, EU GMP Annex 11, GDPR, and relevant GxP expectations.

Audit & Inspection Readiness
Assessment of system controls, validation documentation, audit trails, and operational processes to support regulatory inspections and quality audits.

Technology Lifecycle Management
Establishing structured processes for change control, periodic reviews, access management, system maintenance, and ongoing compliance oversight.

AI System Validation & Governance
Developing risk-based validation and governance approaches for AI-enabled applications, including explainability, model performance monitoring, and human oversight.

Helping pharmaceutical organizations make informed technology decisions, modernize their PV technology landscape, and align technology investments with long-term business objectives.

Technology Strategy & Roadmapping
Assessment of existing technology environments, identification of improvement opportunities, and development of strategic roadmaps for PV technology transformation.

Enterprise Architecture & Solution Design
Translating complex business requirements into scalable technical architectures, solution designs, and implementation strategies.

Program & Project Leadership
Technology leadership and delivery oversight across complex PV initiatives, from requirements definition and planning to implementation and operational transition.

Vendor & Platform Evaluation
Technical assessment of PV platforms, vendor capabilities, solution architecture, and technology fit to support platform selection and investment decisions.

RFP & Technical Due Diligence
Support for RFP preparation, technical evaluations, vendor selection, proposal reviews, and solution due diligence.

Technology Operations & Vendor Oversight
Establishing governance models, service delivery frameworks, and performance monitoring approaches for ongoing technology operations and vendor management.

Helping pharmacovigilance organizations explore and adopt emerging technologies to improve operational efficiency, strengthen quality, and prepare for the next generation of drug safety operations.

AI-Enabled Pharmacovigilance Solutions
Identifying and evaluating practical AI applications across case intake, data extraction, case processing, medical narratives, quality review, and safety operations.

Intelligent Workflow Automation
Designing automation strategies that reduce repetitive manual activities, streamline PV workflows, and improve operational productivity.

LLM & Agentic AI Solutions
Exploring Large Language Models (LLMs) and AI agents to support complex pharmacovigilance workflows, knowledge management, document processing, and decision support.

AI Architecture & Solution Advisory
Evaluating AI models, solution architectures, integration approaches, and deployment strategies for regulated pharmacovigilance environments.

Responsible AI & Regulatory Readiness
Establishing approaches for AI governance, risk assessment, explainability, validation, human oversight, and continuous performance monitoring.