SOARING HEALTH

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

We talk a lot about regulatory, grade RWE, but there's a gap most teams aren't addressing yet: the registration problem....
06/19/2026

We talk a lot about regulatory, grade RWE, but there's a gap most teams aren't addressing yet: the registration problem. ISPOR, ISPE, NPC, and Duke Margolis just launched a registration site specifically for RWE studies using secondary data. The reasoning is straightforward. Studies that don't meet formal regulatory registration requirements still need transparent, preregistered methods to hold weight with payers and assessors.

The issue is perception. RWE without public preregistration gets treated as less rigorous than clinical trials, even when the underlying data is solid. This matters for market access conversations because payers are increasingly skeptical of evidence that wasn't locked in before analysis.

If you're building RWE strategies for value communication, this is operational. Your teams need to know: preregistration isn't optional anymore. It's the difference between evidence that gets debated and evidence that moves decisions.

HEOR Explained is an accessible way to understand what HEOR is, how it’s used, and its impact on people and healthcare systems. A resource for all, created by ISPOR.

Payer scrutiny has reached a new intensity. Accelerated approvals, surrogate endpoints, products with minimal long-term ...
06/17/2026

Payer scrutiny has reached a new intensity. Accelerated approvals, surrogate endpoints, products with minimal long-term data- this is the environment your market access team navigates now. The response from most pharma leaders? Present the Phase III data and hope for the best.

That doesn't work anymore. A recent survey of 25 market access decision-makers across national and regional health plans found something decisive: RWE has become indispensable for determining value and supporting coverage decisions. Not helpful. Indispensable.

Payers aren't looking for more clinical trial summaries. They need evidence from the healthcare systems and patient populations they actually serve. Claims data. EHR patterns. Real treatment adherence across diverse demographics. Cost implications in their specific market.

This shifts where you should be investing your evidence-generation resources. Start with the data payers need to make decisions, not the data that's easiest to collect.

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.

The real-world evidence solutions market is projected to reach 5.6 billion by 2030. But growth alone doesn't guarantee s...
06/12/2026

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.

Payers are done with RWE that sits in a vacuum. I've been tracking what decision-makers actually want, and the pattern i...
06/11/2026

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.

There's an uncomfortable gap between what we measure in clinical trials and what actually happens when patients use ther...
06/09/2026

There's an uncomfortable gap between what we measure in clinical trials and what actually happens when patients use therapies in the real world. I was reading about how exercise increases blood flow to the brain by 15%, and it struck me: we know this works, we have the data, but in healthcare, we're still struggling to translate these kinds of real-world behavioral and physiological insights into the evidence frameworks that payers and health systems actually use for decision-making.

We talk about real-world evidence constantly in our work. RWD from claims databases, EHR analysis, patient registries. But most of this data tells us WHAT happened, not WHY it happened or HOW it translates to better outcomes for the populations that matter most.

The gap isn't in the data collection anymore. It's in the translation. How do we take what we know works in practice and build the health economic arguments, the budget impact models, the value narratives that move the needle with payers?

That's where the real work is. Not generating more evidence. Generating the RIGHT evidence and communicating it in the language decision-makers actually speak.

Start getting more oxygen to the brain with these 10 research-based activities that you can start doing today.

Regulators are finally accepting what we've known for years: real-world data matters. The FDA's updated framework in Jun...
06/08/2026

Regulators are finally accepting what we've known for years: real-world data matters. The FDA's updated framework in June 2026 opens doors for RWE to support regulatory submissions when methodological rigor is demonstrated. But here's what I'm seeing across teams right now. The constraint isn't access to claims databases or EHR systems anymore. It's organizational maturity. Most organizations still struggle to translate massive datasets into decisions and relevant questions that actually influence outcomes. You can have perfect data infrastructure and still miss the insight that moves the needle for your payer. The teams that win are building evidence generation as a continuous learning system, not a one-time study. They're asking: what do we need to know next? How do our findings change our strategy? That iterative mindset separates defensive evidence from evidence that drives real market access wins.

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.

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.

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