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success story

How AI transformed FDA readiness for life-saving trials

Ahead of a pivotal Phase 3 trial, a leading life sciences company known for developing critical therapies partnered with Virtusa to strengthen FDA inspection readiness. Through agentic AI-powered simulation, Virtusa identified workflow gaps, guided corrective actions, and streamlined preparation—boosting compliance, reducing manual effort, and helping ensure timely patient access to life-saving treatments.

KEY SERVICES AND TECHNOLOGIES

Agentic AI simulation
Regulatory advisory
Workflow analysis
Automated content review
Risk and gap assessment

The challenge

Inspection readiness: A high-stakes challenge

When clinical trial preparedness is uncertain, the risk isn’t just operational—it’s a matter of life and death. A leading life sciences organization known for developing breakthrough therapies for chronic and rare diseases faced the possibility of a Phase 3 trial delay due to fragmented workflows and limited visibility into inspection preparedness. With Food and Drug Administration (FDA) scrutiny looming, even minor gaps in documentation, training, or protocol adherence could trigger compliance flags, jeopardizing trial continuity. The consequences? Regulatory setbacks, delayed approvals, and postponed patient access to critical therapies. Preparing for FDA inspections meant navigating 14 complex workflows. Each involved high-stakes coordination across teams, systems, and data sources. Manual effort was high, timelines were tight, and the cost of failure was not just dollars but lives.

With Phase 3 success at stake, the company engaged Virtusa to rethink inspection preparation—combining domain expertise and agentic AI to improve compliance and reduce operational strain.

Built and deployed in just 11 weeks as a proof of concept using the Virtusa Helio platform, the solution brought speed without compromising rigor.

The Solution

From simulation to action, powered by AI

Virtusa deployed a team of agentic AI assistants based on the Virtusa Helio platform to simulate real-world FDA inspections across 14 critical clinical workflows. Each AI agent was configured to walk through processes just as an inspector would—surfacing gaps in documentation, standard operating procedures (SOPs), training records, and protocol compliance.

But the system didn’t stop at detection. Using intelligent prompts, automated cross-checks, and contextual document matching, it guided teams on how to close the gaps quickly and accurately. Domain experts collaborated with business teams to tune the system, validate AI outputs, and prioritize high-risk areas. Built and deployed in just 11 weeks as a proof of concept (PoC) using the Virtusa Helio platform, the solution brought speed without compromising rigor. Within weeks, the organization moved from reactive checklists to proactive simulation, cutting manual prep time, improving cross-team alignment, and improving inspection preparedness.

The Benefit

From effortful prep to confident readiness

By automating simulation and surfacing risk areas early, the organization significantly reduced the burden of manual preparation. Teams gained visibility into readiness gaps—enabling timely, targeted interventions.

Key outcomes included:

End-to-end simulation of inspection workflows across 8 critical domains, mirroring inspector behavior
Early detection of documentation gaps, outdated SOPs, and training lapses
Proactive issue resolution enabled by AI-guided interventions
Reduction in manual effort through intelligent cross-checks and document matching
Improved alignment across quality, regulatory, and business functions
Accelerated inspection readiness with minimal disruption to ongoing operations

The results laid the groundwork for continued collaboration—positioning Virtusa’s domain-tuned AI accelerators as a catalyst for long-term compliance confidence.

Next steps

Beyond readiness: Building resilience with AI

Virtusa was selected to lead the PoC based on its experience in regulated environments and its ability to operationalize AI innovation. The solution leveraged Virtusa’s deep understanding of clinical workflows and inspection protocols, resulting in a technically robust and practically effective simulation. With the PoC successfully delivered, both teams are now evaluating opportunities to scale the agentic framework into broader quality systems and high-risk workflows.