SOARING HEALTH

08/28/2026

GenAI is compressing RWE study cycle times by 30 to 40 percent. That's not marginal. That's the difference between launching evidence strategies that actually influence market access decisions and launching them after the window has closed.

Structuring unstructured clinical data. Automating study reports. Detecting safety signals from free text sources faster than manual workflows. This is happening now at scale.

The practical implication for HEOR teams: RWE infrastructure can no longer be outsourced. It's not a vendor relationship or a tactical add-on. It's core operating capability. The organizations moving evidence from clinical trials into real-world validation at speed are the ones building AI-augmented workflows into their evidence generation workflows, not bolting them on afterward.

If your organization still views RWE as supplementary, the timeline has shifted. Speed of evidence translation is becoming the limiting factor in market access, not data availability.

08/27/2026

The RWE industry is consolidating at speed. But consolidation isn't really about data volume. It's about defensibility. Datavant acquired Aetion in July 2025. Tempus hit 1.1 billion dollars in contract value. Flatiron tripled its global research network. Paradigm acquired Flatiron's clinical research business in early 2026.

Payers and regulators are no longer asking whether RWE should inform reimbursement decisions. They're demanding it. That shift means pharmaceutical companies need end-to-end evidence platforms with regulatory acceptance across FDA and EMA. You can't build that internally, and you can't bolt it together from three vendors.

The cost of not investing in this capability now isn't just a competitive disadvantage. It's a market access bottleneck. The companies winning on reimbursement in 2026 aren't scrambling for data. They've already embedded RWE infrastructure into how they develop and launch therapies.

Explore the state of Real-World Evidence (RWE) analysis in 2025-2026. This guide covers RWD sources, analytical methods, FDA/EMA regulatory frameworks, ICH E6(R3), synthetic control arms, AI-driven RWE platforms, and compares RWE with RCTs

08/26/2026

Most pharma teams treat RWE platform selection as a vendor decision. It's not. It's a portfolio decision. The sophisticated organizations I work with are running two or three complementary platforms wired together because underlying data types are not interchangeable. Claims data tells a different story than EHR data, which tells a different story than patient-reported outcomes.

But here's where I see the real breakdown: teams evaluate platforms in isolation from regulatory acceptance and data model direction. They pick based on what works today, then hit month 18 and realize the platform no longer fits their submission timeline or payer requirements.

ICH E6(R3) finalized in January 2025 and adopted by FDA in September 2025 has shifted what counts as regulatory, grade evidence. The standards are tighter. The expectations are higher.

If your evidence strategy is built on a single platform or single data source, you're already behind. The market has moved.

Compare Aetion, Flatiron, TriNetX, IQVIA, Optum and more. Nine evaluation criteria, pricing models, and a 90-day POC framework for RWE.

08/25/2026

Payers are finally asking the right question: not whether a drug works in a trial, but whether it actually works for their patient population. I've watched regulatory bodies shift dramatically over the past 18 months. What used to be a supplementary data source is now central to how approvals happen. The FDA and EMA increasingly expect RWE alongside traditional trial data, and payers are building reimbursement decisions around it.

The infrastructure is catching up too. AI-powered analytics platforms are making it possible to pull signal from claims data and EHR records at scale. But the real bottleneck isn't the technology. It's the translation layer. Most pharmaceutical teams still operate in silos, treating RWE as an afterthought rather than a foundational strategy.

The teams moving fastest are embedding outcomes research and HEOR into clinical development from day one. They're not waiting for Phase 4 to think about real-world value. They're asking clinicians and payers upfront what evidence actually matters for formulary placement.

If your organization is still treating RWE as a regulatory checkbox, you're leaving money and credibility on the table.

Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

08/21/2026

The FDA released its April 2026 guidance on real-world evidence for medical devices, and the pattern is clear: regulatory agencies are no longer asking if RWE belongs in decision-making. They're asking how you're using it. For pharmaceutical and biotech teams, this signals something important. The bar for evidence packages isn't widening into softer standards. It's shifting toward specificity. Payers want to see outcomes measured in actual patient populations. Health systems want to understand effectiveness in their specific populations, not abstract trial cohorts.

This changes what outcomes researchers and market access teams need to deliver. It's not about generating more data. It's about translating real-world data into insights that matter to decision-makers with limited budgets and patience for theoretical arguments.

The organizations winning right now aren't the ones with the biggest datasets. They're the ones asking better questions about what their real-world data actually means for payer coverage and patient access.

The FDA's use of real-world data and real-world evidence in regulatory decision-making.

08/20/2026

In March 2026, the EMA published its final Real-World Data Quality Framework for EU medicines regulation. The FDA followed suit with ICH M14, a harmonized standard for non-interventional pharmacoepidemiological studies. Sounds procedural. It's actually a shift.

For years, companies treated RWE collection and submission as a post-launch compliance checkbox. Data went in, evidence came out. Now both agencies are setting explicit operational standards: how you design the study, analyze the data, source the records. An EHR export no longer qualifies as safety evidence.

This means internal teams can't delegate this to the data warehouse. Your HEOR, medical affairs, and clinical operations need alignment on methodology before you even pull the data. That requires infrastructure, process discipline, and someone accountable for the quality standard itself.

The companies moving faster aren't the ones scrambling after approval. They're embedding RWE strategy into development planning and regulatory submissions. The companies waiting until post-launch are now facing methodological rework they didn't anticipate. If your organization treats RWE as a compliance event rather than a strategic asset, the 2026 guidance just made that a visible liability.

Explore how FDA and EMA are integrating real-world evidence into drug approval frameworks, and why RWE analytics matter for regulatory strategy in 2026.

08/18/2026

The global real-world evidence solutions market is projected to grow from $22.3 billion in 2026 to $65.42 billion by 2034. That explosive growth isn't hype. It reflects genuine demand from payers and regulators who are tired of surprises post-launch. What's driving it? Payers like NICE in the UK are now formally accepting RWE in their evaluation processes, particularly for treatments with significant uncertainty. The EMA launched DARWIN EU, a centralized network for generating real-world evidence across European data partners. And pharmaceutical companies are investing heavily in specialized RWE platforms and analytics capabilities.

But here's what matters for your strategy: market access teams are increasingly expected to provide real-world validation of therapeutic value to secure optimal formulary positioning. This isn't optional. It's the baseline expectation.

Let's ensure the evidence generation conversation happens in clinical development, not in the market access war room three months before launch. That's where the best outcomes happen.

How pharma leaders can leverage real-world data and evidence (RWE) as a sustainable competitive advantage across the value chain.

08/13/2026

The tension everyone avoids: payers say they want RWE, but the data they're receiving is fragmented, outdated, or missing critical context. A 2024 AMCP initiative identified a fundamental problem. Real-world data exists everywhere: claims systems, EHR networks, registries- yet actionable insights remain scarce. Teams are stitching together disparate datasets from different vendors just to answer basic questions like how a therapy performs across patient subgroups with comorbidities. This is where HEOR professionals face their real challenge. It's not about collecting more data. It's about translating messy, real-world information into the specific economic and clinical narratives that drive coverage decisions. AMCP's November 2024 Partnership Forum brought payers and pharma together to develop standardized RWE criteria for formulary decision-making. The standards framework now exists. What's missing is the operational discipline to apply it consistently. That's where strategic RWE planning, before launch, becomes essential to competitive market access.

RWE has enormous potential, but payers need consistent standards to evaluate quality and reduce bias. AMCP is building frameworks, education, and multi-stakeholder collaboration to increase confidence and consistency in RWE use.

08/07/2026

Regulators are increasingly accepting real-world data to support safety monitoring, effectiveness assessment, and even regulatory submissions. But here's what I'm seeing in practice: many pharma and biotech teams still collect the data without translating it into decisions.

Electronic health records, claims databases, registries, digital health streams. The sources exist. Yet according to recent analysis, despite unprecedented growth in these data sources, organizations struggle to turn real-world datasets into actionable insights for payers and providers.

The gap isn't data availability. It's methodological rigor. It's knowing which variables matter to health systems. It's building analysis that answers the question payers actually ask: does this therapy deliver value outside the trial setting? That translation work is where real-world evidence becomes real-world impact.

Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

08/04/2026

Pfizer's approach to evidence planning offers a practical model most mid-size organizations overlook: treat your clinical programs and real-world evidence as one integrated lifecycle, not separate streams. Instead of running RWD studies after regulatory approval as an afterthought, they identify evidence gaps during clinical development and design RWE strategies to close them before payers even ask. This integrated mindset anticipates what regulators, payers, and patients will need across the full product lifecycle.

The resource question becomes clearer with this frame. You're not adding more studies. You're sequencing your evidence generation with intentionality so each pillar gets the rigor it deserves. Early identification of gaps means you're collecting the right data at the right time, not scrambling to backfill evidence years later.

Pfizer partnered with Premier Applied Sciences to raise the bar for real-world evidence (RWE) as an engine for quality, credibility and impact in regulatory and scientific decision-making.