Why Are Local Literature Workflows Still Disconnected from Global Systems?

Pharmacovigilance has become one of the most regulated, scrutinized, and constantly evolving functions within life sciences. As global markets expand and regulatory expectations tighten, the need for accurate, timely, and compliant safety surveillance has never been greater. Yet despite significant technological advancements in safety databases, automation, and AI, one long-standing pain point remains: local literature monitoring.

Across the world, local journals, regional publications, small medical bulletins, and country-specific scientific outlets continue to serve as critical sources of safety information. Regulatory authorities such as the EMA, FDA, Health Canada, PMDA, and numerous others expect marketing authorization holders to routinely screen local literature for adverse events, lack of efficacy reports, misuse, medication errors, and other reportable safety signals. These requirements apply globally, regardless of market size or language.

However, in most organizations, the workflows surrounding local literature monitoring remain slow, manual, and significantly disconnected from more centralized systems. This disconnect introduces operational inefficiencies, compliance risks, and avoidable delays in signal detection and case processing.

The key reasons behind the fragmentation, the consequences of disconnected processes, and how newer platforms like Tesserblu can finally bridge the gap is briefed below.

1. Diverse Global Requirements Make Standardization Difficult

One of the biggest challenges is that no two regulatory environments are identical. Each authority maintains its own rules, reporting timeframes, expectations for literature screening frequency, and guidelines on which journals qualify as valid sources.

For example, the EMA requires weekly monitoring of local literature across all EU member states, while emerging markets often issue additional country-specific instructions. Some countries mandate review of both indexed and non-indexed journals. Others require retention of search logs or proof of journal unavailability. These differences make global standardization difficult.

Centralized systems struggle to reconcile these variations because they must adapt to the specificity of local requirements. As a result, local safety teams often create parallel workflows tailored to their market. These workflows rarely integrate directly with global systems, perpetuating the disconnect.

2. Lack of Digital Access to Local Journals

While major scientific journals are indexed, digitized, and accessible through international databases like PubMed, Scopus, and Embase, many local journals are not. Numerous regional publications still circulate in print form or through outdated local websites without structured metadata, APIs, or reliable search functions.

Because global systems are designed to integrate with digital sources, they cannot easily ingest content that exists only in offline or semi-digital formats. Consequently, local teams resort to manual searches, manual downloads, or manual review of scanned copies. These analog processes are inherently incompatible with the data standards of global pharmacovigilance systems.

3. Language Barriers and Limited NLP Availability

Global pharmacovigilance tools frequently perform well for English-language publications but struggle with less common languages, non-Roman alphabets, and regional dialects. Natural language processing for pharmacovigilance requires domain-specific ontologies and sensitivity to medical terminology. Creating accurate NLP models for every world language is resource-intensive and often commercially unfeasible.

This forces local teams to perform manual reading or interpretation of literature in their native languages before producing summaries or safety-relevant extracts. Because much of this work occurs outside centralized platforms, it creates silos in the safety data ecosystem.

4. Fragmented Vendor and Outsourcing Models

Many organizations outsource local literature monitoring to country affiliates, local vendors, or regional partners. While this can reduce operational burden, it introduces variability in:

Process documentationSearch methodologySearch frequencyTools used for screeningData transmission formatsQuality control procedures

Each partner introduces its own workflow, often incompatible with the global pharmacovigilance system. As a result, organizations receive scattered outputs, reportable cases in inconsistent formats, and search logs that need manual consolidation. The absence of a unified framework leads to significant process disconnection.

5. Slow Adoption of Automation in Local Contexts

Automation has made significant progress in global safety systems, yet adoption remains slow at the local level for several reasons:

Limited budget allocation for smaller marketsLower availability of validated automated tools for local languagesLocal vendors reluctant to invest in new technologiesPerceptions that automation is not compatible with small-volume workflowsRegulatory caution regarding machine-assisted medical review

Because automation is unevenly adopted, local literature workflows frequently operate on legacy models while the rest of the organization moves forward. This widening gap further disconnects local processes from global systems.

6. Poor Integration Capabilities in Traditional PV Platforms

Historically, pharmacovigilance systems were designed around case processing, signal detection, and regulatory reporting. Literature surveillance was treated as a peripheral activity rather than a core workflow. As a result, integration points for local literature were minimal or nonexistent.

Traditional PV systems often lack capabilities such as:

Automated ingestion of local literature outputsStandardized templates for search logsFlexible integrations with external vendorsMulti-language text analyticsCustomizable workflows for country-specific processes

Because these systems were not designed with local literature in mind, local teams developed their own workarounds, tools, and repositories. These local solutions rarely integrate directly with the central safety ecosystem, cementing the disconnect.

7. Lack of Real-Time Visibility and Governance

When literature monitoring is decentralized, global safety teams struggle to maintain visibility into:

Which journals are being monitoredHow frequently searches are performedWhether all regulatory-required sources are coveredWhat outputs have been generatedWhat potential cases have been identified

Without real-time oversight, organizations face risks such as missed deadlines, inadequate coverage, and inconsistent quality. Many rely on periodic audits and manual compliance checks, which widen the gap between local and global teams instead of closing it.

8. Operational Culture and Inertia

Pharmacovigilance is a conservative domain, and understandably so. Patient safety, regulatory compliance, and data accuracy are at stake. As a result, change is often slow. Many local affiliates have used the same processes for years and feel little incentive to modify them, particularly when volumes are small.

There is also a perception that global integration would require significant effort without clear ROI. These cultural and organizational barriers prevent modernization and contribute to fragmented, disconnected workflows.

Consequences of Disconnected Local Literature Workflows

The disconnect between local and global systems is more than an operational inconvenience. It introduces serious risks and inefficiencies:

Delayed signal detectionInconsistent compliance across marketsHigher likelihood of missing reportable casesManual errors in data entry or translationIncreased audit findingsDuplication of effortLack of global oversightDifficulties in scaling processes

At a time when regulatory expectations are becoming more stringent and global health risks more complex, organizations cannot afford these gaps.

How Tesserblu Can Help Bridge the Disconnect

Tesserblu is specifically designed to address the longstanding disconnect between local literature workflows and global pharmacovigilance systems. It modernizes the process without disrupting established compliance frameworks. Here is how it solves the core challenges:

1. Unified Platform for Global and Local Literature

Tesserblu brings all literature monitoring processes into a single environment. Local teams can perform searches, upload documents, track journal coverage, and record search logs within the same system used by global teams. This delivers consistent structure without removing the flexibility needed at a regional level.

2. Automated Ingestion of Local Sources

The platform supports multiple ingestion methods:

Direct uploadsScanning and OCR for print journalsAutomated data extraction from local websitesStructured and unstructured data formats

By converting all sources into standardized digital workflows, Tesserblu eliminates the barriers created by non-indexed or non-digitized journals.

3. Multi-Language AI and NLP Built for Pharmacovigilance

Tesserblu’s AI models are trained to process medical content across numerous languages. The platform recognizes adverse events, medical terms, products, and safety-relevant entities. This reduces the manual burden on local teams while ensuring high-quality outputs.

4. Seamless Integration With Global Safety Systems

Tesserblu integrates with safety databases, case management systems, and enterprise signal detection platforms. Extracted cases or relevant literature findings flow automatically to global functions. This eliminates manual transfer, reduces errors, and accelerates case intake.

5. Real-Time Compliance and Audit Trails

The platform provides complete visibility into:

Search activitiesJournal monitoring listsReview statusDetected safety informationAffiliate compliance

Audit-ready logs are automatically generated, ensuring transparency across all markets.

6. Standardized Yet Flexible Workflows

Tesserblu allows global teams to define standardized processes while enabling local affiliates to adapt workflows based on regional requirements. This balance creates consistency without imposing rigid constraints that might hinder local compliance.

7. Scalable Automation That Works for All Market Sizes

Whether a country screens five journals or fifty, the platform scales seamlessly. Automation accelerates tasks regardless of volume, allowing even small affiliates to modernize without heavy investment or operational strain.

Conclusion

Local literature remains one of the most important yet most challenging components of pharmacovigilance. Despite global advancements in automation and safety technology, local literature workflows often operate in isolation, hindered by fragmented regulations, limited digital access, language barriers, outdated systems, and cultural inertia.

This disconnect creates operational inefficiencies and compliance risks that global teams must work harder each year to manage.

Modernizing these workflows is both necessary and achievable. Platforms like Tesserblu are built to unify, automate, and elevate local literature monitoring. By integrating local activities with global systems, organizations can improve compliance, enhance signal detection, reduce manual burden, and create a more connected, efficient safety ecosystem. Book a meeting if you are interested to discuss more.