The Challenge
A leading life science organisation was facing a growing operational challenge.
As adverse event volumes increased across regional hubs, safety teams were required to process thousands of ICSRs, medical records, CIOMS forms and supporting documents across dozens of languages. Case volumes fluctuated dramatically creating significant pressure on internal teams.
Traditional translation workflows relied heavily on manual intake, email-based project management and extensive human translation effort. Safety information often required translation, specialist review and rigorous quality assurance, creating a constant challenge between maintaining compliance and meeting demanding reporting timelines. The complexity of scanned documents, handwritten notes, graphics, formatting challenges and multiple file types only added to the operational burden, making cost control increasingly difficult.
The organisation needed a solution that could:
- Accelerate multilingual case processing without compromising quality
- Reduce operational burden on pharmacovigilance teams
- Scale instantly during periods of high demand
- Protect sensitive patient data
- Maintain compliance with global safety reporting requirements
- Automate case intake and delivery through a seamless API integration
The Solution
THG Fluently implemented an AI-powered multilingual processing ecosystem designed specifically for Pharmacovigilance operations, combining automated case import and export through an API integration, intelligent use of linguistic input, specialist PV expertise and regulatory-grade quality assurance.
Intelligent Case Processing
Incoming ICSRs and supporting documentation were automatically routed through an AI-enabled workflow into THG Fluently’ s secure translation environment. Files were triaged based on serious and non-serious cases with multiple AI agents validating the translations against MedDRA terminology, domain and therapeutic specialisms, client-specific style guides, glossaries, work instructions and Translation Memory assets.
Adaptive Quality Assurance
Rather than applying the same review process to every case, THG Fluently’s AI-powered quality framework used dynamic risk thresholds to determine the appropriate level of scrutiny required. A proprietary traffic-light system automatically identified critical safety information and introduced additional layers of expert review where patient safety or regulatory impact was highest, while enabling lower-risk cases to progress through a streamlined workflow. The result was a more efficient operating model that accelerated delivery without compromising quality, compliance or regulatory confidence.
Specialist PV Expertise
Dedicated PV project teams, BHBIA-certified project managers trained in Adverse Event handling, and a global network of ISO-certified linguists specialising in Pharmacovigilance and clinical studies ensured every case benefited from deep domain expertise, regulatory understanding and exceptional linguistic quality.
Built to Scale
Combining AI-enabled automation with a mature global network of specialist PV linguists and 24/7 delivery hubs, THG Fluently gave the client the flexibility to scale instantly in response to reporting surges, regulatory deadlines and seasonal fluctuations while maintaining consistent turnaround times.
The Results
Within months of implementation, the client transformed its multilingual case processing operation.
Average multilingual ICSR turnaround times were reduced from multiple days to just a few hours, enabling same-day turnaround for both serious and non-serious cases, while critical safety reports were prioritised through expedited workflows to support urgent regulatory reporting requirements.
API-enabled workflow automation removed thousands of hours of manual file handling, email management and project coordination annually.
The client gained access to a 24/7 global operating model spanning EMEA, APAC and the Americas, allowing rapid response to unexpected reporting surges without increasing internal headcount.
Automated patient data detection and redaction reduced privacy risks, while risk-based quality controls validated critical elements such as dosage information, units of measurement and handwritten medical notes. Real-time quality reporting provided a clear audit trail and evidence of compliance, supporting consistency, traceability and regulatory readiness throughout the process.
By combining AI translation with targeted human review, the client reduced multilingual processing costs by more than 70% compared to traditional translation workflows while maintaining the quality standards required for regulatory reporting.
The THG Fluently Difference
The success of the programme was driven by an AI-enabled workflow that leveraged multiple specialist AI agents and rigorous Multidimensional Quality Metrics (MQM) scoring to transform the speed, scalability and cost-efficiency of multilingual pharmacovigilance operations. Combined with project managers trained in adverse event handling, subject-matter expert linguists and an adaptive approach to human oversight, THG Fluently enables organisations to accelerate safety reporting, significantly reduce multilingual processing costs and maintain the highest standards of quality, compliance and patient safety.
More than a translation provider, THG Fluently is a strategic technology partner backed by the THG Ingenuity ecosystem. Supported by ongoing investment in AI innovation and THG Ingenuity’s partnership with Google Cloud, THG Fluently combines specialist linguistic expertise with enterprise-scale technology to deliver the next generation of multilingual pharmacovigilance operations.