Pharmacovigilance: Are you suffering from Shiny Object Syndrome, or being truly strategic about Digital Transformation?

Digital transformation in Pharmacovigilance (PV) remains a central theme across the industry. While the concept itself is not new, what often receives less attention is the strategic lens through which transformation decisions are evaluated and executed.

Across the sector, the aspiration is clear: organizations envision fully interconnected ecosystems in which data flows seamlessly across systems while maintaining compliance with privacy requirements, cybersecurity standards, and global regulatory expectations. It is an elegant and compelling vision — one that promises efficiency, transparency, and scalability.

Despite the appeal of this vision, industry data consistently indicates that more than 70 percent of digital transformation initiatives fail.

The root cause is rarely technological limitation. More frequently, failure stems from the absence of a clearly defined strategy that aligns business priorities, risk appetite, governance models, and operational readiness before architectural decisions are made.

Technology alone does not create transformation. Strategic clarity does.

Interoperability between selected systems is achievable. However, expecting a single platform to comprehensively address every digital requirement across the entire PV value chain remains largely aspirational.

The reason lies in inherent trade-offs within broad, multi-functional platforms.

For example, a platform may deliver strong CRM capabilities, but that does not automatically translate into equivalent depth in Safety, Regulatory, or Medical functionalities.

A useful analogy can be drawn from photography. Professional photographers continue to rely on specialized DSLR cameras rather than smartphones. While both capture images, tools designed with a singular focus typically deliver greater precision. Similarly, products engineered to solve specific challenges often provide a level of refinement that broader platforms cannot consistently replicate.

Only a limited number of legacy PV systems have evolved over multiple decades, benefiting from continuous refinement and regulatory adaptation.

Replicating that level of functional depth within a newly built ecosystem is not simply a technical exercise. It requires:

• Sustained change management
• Continuous system validation
• Revised SOP frameworks
• Extended operational adjustment

Organizations must therefore evaluate whether they possess the risk appetite, internal capacity, and long-term commitment required for full-scale disruption.

In practice, three broad strategic approaches to digital transformation typically emerge:

1. Harvest

The Harvest strategy focuses on optimizing the existing environment through incremental improvements with minimal risk exposure. It strengthens current capabilities without structural overhaul.

2. Disrupt

The Disrupt strategy represents comprehensive reinvention of the ecosystem. It often involves significant investment, extended timelines, and higher short-term risk in pursuit of long-term returns.

3. Transform or Extend

Positioned between these approaches, Transform or Extend selectively modernizes the landscape while preserving a stable operational core.

Harvest optimizes the present.
Disrupt reinvents the future.
Transform or Extend provides a balanced path that delivers meaningful modernization with controlled risk.

At the heart of the Transform or Extend model lies a foundational principle: build around a stable nucleus.

If the existing Safety system is reliable — even if not perfectly efficient — replacement may not be necessary. Instead, the broader ecosystem can be enhanced by integrating purpose-built solutions that address clearly defined inefficiencies.

Examples include:

• Automating follow-up cycles between the Safety database and reporters
• Streamlining health authority downloads that otherwise require substantial manual effort
• Automating intake from structured and unstructured data sources

In this model, the nucleus remains stable and protected, operational disruption is minimized, and each solution delivers value aligned with its specific design intent.

Organizations adopting a use-case-driven modernization strategy often achieve measurable outcomes compared to broad, platform-driven transformation initiatives.

Ultimately, the differentiator is not merely the chosen strategy — it is the discipline of execution.

Deep discovery, thoughtful solution architecture, and structured implementation are essential to ensuring that modernization strengthens rather than destabilizes the organization.

Without disciplined execution, even the most promising strategy can introduce unnecessary risk.

Digital transformation in Pharmacovigilance should not be driven by industry momentum or technological novelty.

It should be an intentional, risk-calibrated decision grounded in business clarity, regulatory awareness, and operational reality.

True transformation is not about adopting the newest platform.
It is about aligning modernization with strategy.

Article authored by Ratika Dhar, Chief Strategy Officer.