However, the literature surveillance process is becoming increasingly complex. Safety teams need to monitor global and local literature sources, manage high volumes of references, review multilingual content, assess potential case relevance and maintain clear documentation for quality and compliance purposes. For companies managing multiple products, regions and therapeutic areas, this can place significant pressure on internal safety teams.

PrimeVigilance combines experienced pharmacovigilance review with technology-enabled workflows to help make literature surveillance more efficient, structured and scalable. One of the ways we support this is through ReTrans, an intelligent literature screening capability designed to support faster review, automated translation, structured case submission and stronger quality control.

Streamline literature surveillance with confidence. Speak to our team.

 

Why literature surveillance can be difficult to scale

Literature surveillance is not simply a search activity. It requires carefully developed search strategies, consistent screening, accurate assessment of potentially relevant safety information, access to full-text articles where needed, and clear documentation of decisions and outputs.

The process can become particularly resource-intensive when safety teams need to manage large reference volumes, local literature requirements, multilingual publications, multiple product portfolios and tight reporting timelines. Manual tracking can also add complexity, especially when teams rely on spreadsheets, disconnected workflows or repeated handoffs between reviewers, quality control teams and case processing teams.

For this reason, technology can provide significant operational value — but only when it is integrated into a controlled pharmacovigilance process and supported by expert human review.

 

What ReTrans adds to literature surveillance

ReTrans supports literature surveillance by helping streamline key steps across the review and assessment workflow. Its capabilities include automated translation, automated pre-assessment, NLP-supported classification, workflow tracking, quality control support and structured outputs for case submission.

This means that potentially relevant references can be prioritised more efficiently, multilingual literature can be reviewed more consistently, and repetitive manual steps can be reduced. ReTrans also supports clearer visibility of work status and outputs, helping safety teams manage the literature surveillance process in a more structured way.

Importantly, ReTrans does not replace pharmacovigilance expertise. It supports the process by helping reviewers focus time and attention where expert judgement is most valuable: assessing relevance, confirming potential safety information, supporting quality control and ensuring that outputs remain aligned with agreed processes and regulatory expectations.

 

Combining automation with expert pharmacovigilance oversight

The strongest literature surveillance models combine technology-enabled efficiency with experienced human review. Automation can support screening, translation, classification, tracking and output generation, but expert oversight remains essential for interpreting scientific and medical information correctly.

At PrimeVigilance, ReTrans is used to support a human-in-the-loop approach. This helps reduce manual effort while keeping pharmacovigilance specialists at the centre of the decision-making process. The objective is not only to process references faster, but to improve consistency, traceability and oversight across literature surveillance activities.

 

From literature reference to case-ready output

ReTrans supports a structured workflow from literature reference identification through to case-ready output. This can include global alert import, local journal checks, automated assessment of global literature hits, manual assessment of local journals, full-text review, translation of applicable articles, classification based on agreed conventions, quality control and the creation of XML case files for confirmed ICSRs.

This structured approach helps reduce manual handoffs and supports a clearer route from literature identification to downstream safety workflows. It can also support archive outputs where needed, giving teams a more organised record of literature review activity.

 

Benefits for safety teams

For safety teams, ReTrans can help reduce manual screening effort, accelerate review and triage workflows, improve consistency across literature surveillance processes, support multilingual surveillance requirements and strengthen quality control oversight.

It can also help teams scale literature monitoring activity without losing sight of compliance, traceability and expert review. This is particularly relevant for organisations managing complex portfolios, multiple territories or increasing literature volumes.

 

Why PrimeVigilance

PrimeVigilance brings together pharmacovigilance expertise, global operational scale, local safety knowledge and technology-enabled delivery. Our literature surveillance team supports clients with systematic monitoring, screening, quality management and the identification of safety information for case reporting, signal detection and aggregate reporting purposes.

With ReTrans, PrimeVigilance helps clients make literature surveillance more efficient, structured and scalable while keeping expert safety review at the centre of the process.

 

Looking to improve the efficiency and scalability of your literature surveillance process? Speak to PrimeVigilance about how our expert-led, ReTrans-enabled approach can support literature screening, translation, case submission and quality control.