SOARING HEALTH

SOARING HEALTH We help drug companies demonstrate real-world evidence through outcomes research.

GenAI is compressing RWE study cycles by 30 to 40 percent. Let that sink in. I just watched a team spend six months stru...
06/05/2026

GenAI is compressing RWE study cycles by 30 to 40 percent. Let that sink in. I just watched a team spend six months structuring claims data that GenAI could have cleaned in weeks. They weren't behind on tools. They were behind in how they thought about the work.

The infrastructure exists now. In 2026, 90 percent of health systems are on electronic records. Wearable devices, pharmacy claims, patient histories. The data pipeline is real. What's lagging is the decision to actually use it.

GenAI handles the heavy lifting: structuring messy unstructured data, automating study reports, detecting safety signals from free text sources. It surfaces patient-level insights that manual workflows miss. But only if you feed it clean data and clear protocols.

The teams moving fastest aren't the ones with the fanciest models. They're the ones who stopped waiting for perfect data and started building repeatable, decision-ready evidence with the data they have today. What's your RWE cycle time looking like right now?

Learn how real-world evidence (RWE) in pharma improves clinical practice. Real-world data (RWD) supports drug development, enhances clinical trial design, and translates data and evidence into improved patient outcomes.

The FDA just removed a key structural barrier to RWE adoption. As of December 2025, they'll accept real-world evidence i...
06/04/2026

The FDA just removed a key structural barrier to RWE adoption. As of December 2025, they'll accept real-world evidence in drug and device submissions without requiring identifiable individual patient data. That's significant because it means organizations can now extract meaningful insights from big data sources that were previously off-limits.

But there's a gap between regulatory acceptance and ex*****on. The FDA removed the submission requirement, yet since 2016 only 35 drugs and biologics have actually included RWE in applications. Devices have moved faster with over 250 premarket authorizations, but even that's plateaued.

The constraint isn't the rule change. It's the infrastructure. Organizations need the data architecture, the analytical rigor, and the governance to produce evidence that regulators actually trust. That's where the real work happens. Have you updated your RWE submission strategy to take advantage of this shift?

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews

Payers are done with RWE that sits in a vacuum. I've been tracking what decision-makers actually want, and the pattern i...
06/03/2026

Payers are done with RWE that sits in a vacuum. I've been tracking what decision-makers actually want, and the pattern is clear: they need evidence that's comparative, actionable, and tied to the outcomes that matter in their formulary reviews.

A recent survey of 25 payer pharmacy and medical directors revealed something crucial. They're making coverage decisions in the first year after FDA approval, but manufacturers often deliver RWE that doesn't answer the specific question payers are asking. It's not about the volume of data anymore. It's about whether the evidence fills a clear gap and shows how a therapy performs against the right comparator in real-world populations.

For HEOR teams building evidence strategies, this is the inflection point. Traditional retrospective analyses without real-world context are losing traction. Payers are scrutinizing comparator choice and asking if outcomes actually hold across diverse patient populations and care settings.

The teams moving the needle are the ones collaborating across market access and outcomes research from the start, designing evidence generation plans that produce data payers can actually use.

Payers demand timely and actionable real-world evidence (RWE) for informed coverage decisions. Get key insights from Precision AQ's survey on RWE's impact on market access strategies.

AMCP just wrapped its 2026 conference in Nashville, and one initiative stands out for anyone building payer-facing evide...
06/02/2026

AMCP just wrapped its 2026 conference in Nashville, and one initiative stands out for anyone building payer-facing evidence strategies: the RWE standards framework for formulary decision-making.

The problem they're solving is real. Payers have been asking for standardized approaches to evaluate RWE submissions, but guidance has been fragmented across regulatory bodies. AMCP's research revealed a critical gap: organizations need an FDA-compliant RWE repository where payers can access high-quality, relevant studies with transparency.

This matters because it signals where the market is moving. Payers aren't just interested in the volume of data anymore. They want clear study designs that meaningfully answer their specific coverage questions. If you're designing evidence strategies, this is worth reviewing.

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.

One thing that keeps coming up in conversations with our clients: the difference between what *should* work in theory an...
06/01/2026

One thing that keeps coming up in conversations with our clients: the difference between what *should* work in theory and what actually moves the needle in practice.

I read something recently about multivitamin absorption and timing. The article made a solid point that consistency matters more than the specific time of day. But it got me thinking about how this applies to evidence generation in our space.

We spend enormous energy optimizing study protocols, statistical models, and data collection methods. And yes, those things matter. But I've seen real world evidence initiatives fail not because the methodology was flawed, but because stakeholders couldn't stay consistent with the program. They lost interest. The data stream dried up. The insights never materialized.

It's the same principle. A good RWE program that runs consistently beats a perfect study that fizzles out halfway through.

The unsexy truth: sustainability of your evidence strategy often trumps optimization of the evidence itself.

Wondering when the best time to take multivitamins is? Get the answer you're looking for by reading our complete guide.

There's a quiet revolution happening in how we validate therapies, and most pharma teams aren't paying enough attention ...
05/29/2026

There's a quiet revolution happening in how we validate therapies, and most pharma teams aren't paying enough attention to it. The Therapeutics Initiative at UBC has been doing something remarkable for years. They're generating independent, evidence-based guidance on healthcare interventions without the noise of commercial incentives. No marketing spin. Just rigorous pharmacoepidemiology work that informs clinical practice.

Here's what struck me: while we spend millions on RWE studies and health economic models to demonstrate value to payers, there's this parallel stream of clinical evidence being generated by academic institutions that shapes how physicians actually prescribe. And frankly, it's not always aligned with how we're positioning our therapies.

If you're in market access or medical affairs, this matters. The evidence that moves prescribers isn't always the evidence that moves formulary committees. One is rooted in clinical effectiveness and safety signals from real populations. The other is rooted in economic value and budget impact.

Neither is wrong. But they're not the same thing.

The question I'm sitting with: how do we better integrate independent clinical evidence streams into our value communication strategy? Because ignoring what organizations like TI are publishing means we're potentially missing critical insights about how our therapies actually perform outside controlled settings.

PharmacoEpidemiology Group (PEG) conducts research in the areas prescription drug utilization, epidemiological research methods, evaluation of drug policy and educational interventions, and drug safety and effectiveness. Selected journal articles and reports co-authored by PEG members are listed bel...

The regulatory landscape for real-world evidence is evolving rapidly. A major milestone occurred with the finalization o...
05/28/2026

The regulatory landscape for real-world evidence is evolving rapidly. A major milestone occurred with the finalization of ICH E6(R3) in January 2025, which formally acknowledges pragmatic trials, registry-based studies, and RWD in clinical research. This represents a fundamental shift in how regulators view evidence generation.

For pharmaceutical and biotech organizations, the implications are significant. Payers increasingly demand RWE to justify reimbursement and negotiate outcomes-based contracts. The competitive advantage will belong to companies who can convincingly demonstrate real-world value beyond traditional clinical trials.

What does this mean for your evidence strategy? Organizations that invest in robust RWE infrastructure now will be positioned to accelerate approvals and strengthen market access discussions. The path forward requires integrated evidence planning that connects regulatory, health economics, and payer perspectives from day one.

How is your organization preparing for this shift? What challenges are you navigating in building credible real-world evidence? Let's discuss in the comments.

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

The real-world evidence solutions market is projected to reach 5.6 billion by 2030. But growth alone doesn't guarantee s...
05/27/2026

The real-world evidence solutions market is projected to reach 5.6 billion by 2030. But growth alone doesn't guarantee success. What matters is how you're deploying RWE across the product lifecycle.

Think about it: AI-powered analytics, expanded RWE platforms, predictive modeling tools, and enhanced collaboration between payers and pharma are reshaping how value gets communicated and reimbursement decisions get made.

Yet many organizations are still operating in silos. Clinical development teams design trials without input from market access. Market access teams craft value stories without input from the data scientists generating the evidence. The result is a disconnect between what you're measuring and what payers actually care about.

The organizations that win are the ones integrating these functions early. Building RWE strategies that align regulatory, clinical, and commercial objectives from day one.

Are your teams working in isolation or in integration? The answer determines your competitive position.

The Business Research Company is a global market research and consulting firm that offers in-depth industry analysis, valuable insights and actionable recommendations. We provide our clients with the information they need to make better business decisions.

Real-world evidence has evolved from a supplementary approach to central to pharmaceutical development and market access...
05/26/2026

Real-world evidence has evolved from a supplementary approach to central to pharmaceutical development and market access strategy. Yet many organizations still struggle with the critical gap: translating vast healthcare datasets into actionable decisions.

The constraint isn't data volume. It's organizational capability. The teams asking the right questions, generating defensible analyses, and ensuring findings drive clinical adoption are the ones winning in market access.

The strategic advantage comes from tighter integration between evidence generation and real-world ex*****on. Organizations that reach institutional maturity in RWE generation will design more efficient trials, support regulatory submissions with greater confidence, and accelerate therapy uptake.

What's your organization's RWE maturity level? Are you still acquiring data assets, or have you moved into advanced analytics and organizational integration?

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.

I've been thinking about the data quality challenge in real-world evidence generation. We have access to massive amounts...
05/25/2026

I've been thinking about the data quality challenge in real-world evidence generation. We have access to massive amounts of RWD from EHRs, claims data, and registries, but handling diverse, complex, and unstructured data at scale remains genuinely difficult. From clinician notes to imaging data, extracting meaningful insights requires more than storage capacity. It requires advanced partnerships and tools that can process and interpret that complexity responsibly. The FDA's framework for evaluating RWE in regulatory decisions has created an accountability standard. Regulators are now expecting pharmaceutical companies to demonstrate that their real-world evidence is fit-for-purpose, methodologically sound, and defensible. This shifts the conversation from quantity of data to quality of evidence. Organizations investing in AI-enabled infrastructure combined with epidemiological expertise are seeing the payoff in faster regulatory pathways and stronger payer negotiations. But this only works if the underlying data is clean, validated, and analyzed with scientific rigor. For HEOR professionals and evidence teams, this is an opportunity to position real-world evidence as a strategic asset rather than a compliance requirement. What does that look like in your organization?

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.

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