What Is the Opportunity Cost of a Slow Literature Review?

In pharmacovigilance, literature review is not a background activity. It is a regulatory obligation, a scientific responsibility, and a direct contributor to patient safety. Global health authorities such as EMA, FDA, MHRA, and PMDA require Marketing Authorization Holders (MAHs) to continuously monitor scientific and medical literature for Individual Case Safety Reports (ICSRs), signals, and emerging safety risks.

Despite its importance, literature review is still one of the most manual, time-consuming, and resource-intensive processes in pharmacovigilance. Organizations often focus on the direct cost of conducting literature reviews—staff hours, vendor fees, and system costs—while overlooking a more significant and less visible factor: opportunity cost.

The opportunity cost of a slow literature review is not just inefficiency. It is delayed risk detection, regulatory exposure, reduced scientific insight, and lost strategic capacity. In a field where timing can directly affect patient outcomes and business sustainability, slow processes carry consequences far beyond operational inconvenience.

This blog explores what opportunity cost means in the context of pharmacovigilance literature review, why speed matters, and how modern solutions such as Tesserblu can help organizations reclaim lost value.

Understanding Opportunity Cost in Pharmacovigilance

Opportunity cost refers to the value of what is lost when resources—time, people, or capital—are tied up in one activity instead of being used for a higher-value alternative.

In pharmacovigilance, opportunity cost is often hidden because compliance tasks are mandatory. Organizations assume that as long as literature screening is performed, the job is done. But the way it is performed matters.

When literature review is slow, the organization is not just spending time; it is losing opportunities to:

• Detect safety signals earlier

• Act proactively instead of reactively

• Allocate skilled professionals to higher-value activities

• Generate real-world evidence insights

• Improve inspection readiness and regulatory confidence

The cost of delay compounds over time, affecting safety, compliance, and strategic decision-making.

Why Literature Review Is Slow in Many PV Organizations

To understand the opportunity cost, it is important to understand why literature review often becomes a bottleneck.

Most organizations still rely on a process that includes:

• Manual or semi-manual searches across multiple databases

• Broad search strategies to ensure compliance

• High volumes of irrelevant publications

• Manual screening of abstracts and full texts

• Manual data extraction for ICSRs

• Multiple layers of quality checks

This process is repeated weekly or monthly for each product, indication, or therapeutic area. As portfolios grow and publication volume increases, the workload expands exponentially.

Scientific publishing has accelerated dramatically, especially in oncology, immunology, rare diseases, and biologics. The volume of literature grows faster than pharmacovigilance teams, creating a widening gap between regulatory expectations and operational capacity.

Opportunity Cost 1: Delayed Safety Signal Detection

The most critical opportunity cost of a slow literature review is delayed detection of safety signals.

Literature is often the first place where emerging adverse events, off-label use risks, or vulnerable population effects appear. Case reports and observational studies can reveal patterns long before they surface in spontaneous reporting databases.

When literature screening takes weeks instead of days:

• Early warning signs may be missed or identified too late

• Signal validation and escalation are delayed

• Risk mitigation measures are postponed

• Patients remain exposed to preventable harm

In pharmacovigilance, speed is not about efficiency alone. It is about protecting patients at the earliest possible moment.

Opportunity Cost 2: Increased Regulatory and Inspection Risk

Regulators expect literature review to be:

• Continuous

• Timely

• Documented

• Auditable

A slow or backlogged literature review increases the risk of non-compliance. During inspections, regulators may question:

• Whether all relevant literature was identified

• How quickly cases were processed

• Whether delays impacted safety actions

• The robustness of quality controls

Inspection findings can lead to:

• Observations or critical findings

• Increased scrutiny in future inspections

• Mandatory remediation programs

• Reputational damage

The opportunity cost here is not just financial penalties, but lost regulatory trust. Once confidence is eroded, organizations spend years rebuilding credibility instead of advancing innovation.

Opportunity Cost 3: Misuse of Highly Skilled PV Professionals

Pharmacovigilance professionals are highly trained in clinical science, regulatory interpretation, signal management, and benefit-risk evaluation.

Yet in slow literature review models, a significant portion of their time is spent on:

• Screening irrelevant abstracts

• Identifying duplicate publications

• Performing repetitive data extraction

• Managing manual workflows

This is a poor use of specialized expertise.

The opportunity cost is the work that these professionals could be doing instead, such as:

• Signal detection and evaluation

• Aggregate report strategy

• Risk management planning

• Cross-functional safety decision-making

• Advanced analytics and insight generation

When talent is consumed by low-value manual tasks, organizations lose intellectual capital and struggle with burnout and attrition.

Opportunity Cost 4: Delayed Insights for Strategic Decision-Making

Literature is not only a compliance requirement; it is a strategic data source.

Scientific publications provide insights into:

• Real-world use patterns

• Comparative safety data

• Emerging competitor risks

• New therapeutic hypotheses

• Population-specific safety concerns

When literature review is slow, these insights arrive too late to influence decisions such as:

• Label updates

• Clinical development strategy

• Market access discussions

• Risk communication planning

The organization becomes reactive instead of data-driven. Opportunities to differentiate on safety, improve patient outcomes, or adjust strategy early are lost.

Opportunity Cost 5: Escalating Long-Term Costs

Ironically, slow manual processes often cost more over time.

Backlogs lead to:

• Overtime expenses

• Increased outsourcing

• Emergency remediation efforts

• Additional quality reviews

As portfolios grow, costs scale linearly or worse, while efficiency remains stagnant.

The opportunity cost is the savings that could have been reinvested into innovation, advanced analytics, or patient-focused initiatives if the process were optimized earlier.

Why Speed Does Not Mean Compromising Quality

One of the biggest misconceptions in pharmacovigilance is that faster processes are less compliant or less rigorous.

In reality, slow manual processes introduce their own risks:

• Human error

• Inconsistent screening decisions

• Fatigue-related mistakes

• Poor traceability

Modern, well-designed technology can improve both speed and quality by applying consistent rules, maintaining full audit trails, and reducing variability.

The real question is not whether to go faster, but how to go faster responsibly.

How Tesserblu Can Help Address the Opportunity Cost

Tesserblu is designed to modernize pharmacovigilance operations by addressing exactly these hidden opportunity costs.

By leveraging advanced automation and intelligent workflows, Tesserblu helps organizations transform literature review from a bottleneck into a strategic asset.

Accelerated Literature Screening

Tesserblu enables rapid identification and prioritization of relevant literature, significantly reducing the time spent on manual screening. This allows safety teams to focus on publications that truly matter, rather than wading through thousands of irrelevant abstracts.

Improved Case Identification and Processing

Through structured data extraction and intelligent workflows, Tesserblu supports faster and more accurate identification of ICSRs from literature, reducing processing timelines without compromising regulatory compliance.

Consistency and Audit Readiness

Standardized processes and built-in traceability help ensure that literature review decisions are consistent, documented, and inspection-ready. This reduces regulatory risk and inspection anxiety.

Better Use of PV Expertise

By automating repetitive tasks, Tesserblu frees pharmacovigilance professionals to focus on higher-value activities such as signal evaluation, risk assessment, and strategic safety planning.

Scalable and Future-Ready Operations

As publication volumes continue to grow, Tesserblu enables organizations to scale their literature review capabilities without proportionally increasing headcount or outsourcing costs.

Reframing Literature Review as a Value Driver

The opportunity cost of slow literature review is not theoretical. It is measurable in delayed signals, increased risk, lost expertise, and missed insights.

Organizations that continue to treat literature review as a purely operational obligation will struggle to keep pace with regulatory expectations and scientific complexity. Those that reframe it as a value-generating activity—supported by modern tools and intelligent automation—will gain a competitive advantage in safety excellence.

Speed in pharmacovigilance is not about cutting corners. It is about removing friction that stands between data and decision-making.

By addressing the opportunity cost of slow literature review and adopting solutions like Tesserblu, pharmacovigilance teams can protect patients more effectively, satisfy regulators with confidence, and unlock the full strategic potential of scientific literature.

In an era of accelerating science and increasing scrutiny, the real question is no longer whether organizations can afford to modernize their literature review processes—but whether they can afford not to. Book a meeting if you are interested to discuss more.