Global Clinical Safety Management System

Industry Context & Pain Points: Drug safety and pharmacovigilance are under growing global scrutiny, driving demand for advanced IT solutions. The pharmacovigilance market is projected to grow from $8.6 billion in 2024 to $9.6 billion in 2025, with a CAGR of 12.5% per year until 2029 https://www.thebusinessresearchcompany.com/report/pharmacovigilance-global-market-report.

Pharmaceutical companies invest heavily in systems to manage adverse event reporting, safety data analysis, and compliance with diverse regulations.

Challenge: The original solution lacked proper documentation and was built with hard-coded, client-specific configurations. The embedded regulatory compliance rules for different countries were undocumented, making scaling especially challenging. Therefore, creating a scalable Clinical Safety Management System is easier said than done – especially when every country has its own rules and protocols. As the original system was essentially a one-off, the platform couldn’t be “lifted and shifted” to other pharma clients without a ground-up transformation.

Industry Pain Point: This scenario reflects a common industry issue, as many pharma IT systems carry huge technical debt. As a recent analysis noted, “Tech debt is no longer just a technical issue; it’s a structural liability. It slows innovation, drains budgets, and locks enterprises into operating models that can’t keep up.” https://www.publicissapient.com/content/dam/ps-reinvent/us/en/2025/05/insights-lp/hfs-ai-tech-debt-report/docs/HFS-PS-Report-SmashTechDebt-2025.pdf

In our client’s case, the technical debt and lack of clear documentation were stalling a significant business opportunity: to turn their bespoke Clinical Safety Management System into a market-leading global clinical safety platform and gain an advantage in a market hungry for modern pharmacovigilance tools.

Solution Approach: AROBS partnered with the partner to reverse-engineer and modernize the Clinical Safety Management System, effectively extracting the “DNA” of the application so it could be replicated and scaled. We stood up three specialized squads, each blending cross-functional skills: seasoned software architects and reverse-engineering specialists, to deal with the legacy code; regulatory compliance experts specialized in FDA, EMA, and ICH guidelines; business analysts who could interpret the thin existing documentation and client workflows; and senior project managers with pharma domain experience to coordinate it all.

Solution: The initiative began with an intensive discovery phase: our teams combed through the codebase and documentation, mapping out all rules and dependencies. In parallel, we consulted Subject Matter Experts (from the original client and industry consultants) to validate each business rule we uncovered. Piece by piece, the AROBS teams decoded the complex logic – from how the system handled multi-country case intakes and triage, to how it enforced varying regulatory timelines for reporting incidents.

The teams successfully extracted, documented, and generalized the Safety Management System’s core functionality while maintaining all critical security and compliance features. The transformation enabled the vendor to create a scalable, configurable global product.

Execution & Outcome: Over the course of the project, AROBS’s three teams worked in parallel on different modules (case management, reporting dashboard, regulatory rules engine, etc.), syncing frequently to ensure the pieces fit perfectly. This agile yet coordinated execution paid off. The result was a transformed “Clinical Safety Management System 2.0″ – a fully documented, configurable solution that preserved the proven effectiveness of the original while making it adaptable to the needs of any pharmaceutical company.

The business outcome: Our client successfully onboarded multiple top pharmaceutical companies onto the new Safety Management System in a remarkably short time. What had started as a single-client application is now a market-leading global Clinical Safety Management System.

The business impact for our client has been expansive: from breaking free of the old code and opening an entirely new revenue stream to positioning themselves as an innovator in the pharmacovigilance space.

Among many other projects, AROBS helped turn legacy into leverage with this one, too. Going above and beyond, the new Clinical Safety Management System enables pharmaceutical companies to enhance patient safety, ultimately delivering value to society. By harmonizing and simplifying compliance, it ensures that adverse events and safety signals are consistently tracked and reported across global operations.