Bioanalysis for Foundations and Patient Groups

The right partner for Foundations and Patient Groups

Most CROs won't even talk to you unless you have 100+ samples. That's a problem if you're running a pilot study or working with a rare disease where you're lucky to get 30 patients enrolled. We built Dash Bio specifically for situations like this—where the science matters but the volume doesn't fit the traditional CRO model.

The other issue is speed. Patient foundations operate on a completely different timeline than pharma. If you're trying to coordinate samples across multiple sites or influence an upcoming clinical trial design, waiting four months for results kills your momentum. Our automated platform gets you GLP-compliant data in 2-4 weeks, which actually matches the pace of advocacy work.

We're also transparent about pricing because nobody likes surprise costs after they've already committed to a study. You get complete upfront pricing—method development, validation, sample analysis, all of it. No hidden fees or change orders halfway through.

This approach works particularly well for a few situations. Biomarker qualification studies need precise data but don't have the volume to interest traditional CROs. Natural history studies for rare diseases generate samples steadily over time rather than in batches, so forcing you into minimum batch sizes doesn't make sense. And investigator-initiated trials usually have tight budgets and deadlines that don't align with how big CROs operate.

On pricing, method development is a fixed cost based on complexity, validation is transparent per-run pricing, and sample analysis is per-sample with volume discounts starting at 30 samples. Everything includes what you'd expect—documentation, repeat analysis if needed, ISR, the works.

All our work runs under GLP, which means documented procedures, calibrated instruments, trained analysts, and complete audit trails. Whether you're filing an IND or publishing research, the data meets regulatory standards. You get the same documentation packages that pharma sponsors use, just adapted for foundation research.

If you want to talk about a specific study, send us the details and we'll have a quote back to you within 48 hours.

Why Patient Foundations Need a Different Approach to Bioanalysis

Most patient advocacy foundations end up working with the same CROs that serve large pharmaceutical companies. This isn't because those CROs are a great fit—it's because until recently, they were the only option for GLP-compliant bioanalysis. But the economics and timelines that work for a Phase 3 trial with thousands of patients create real problems for foundations trying to advance research on rare diseases.

The Volume Problem Blocks Early Research

Traditional CROs built their business models around large pharmaceutical studies. They need hundreds or thousands of samples per project to make the economics work. This creates an immediate barrier for rare disease research, where getting 50 well-characterized patient samples might represent years of work across multiple clinical sites.

The result is that promising biomarkers go untested, natural history studies get delayed, and pilot projects never happen because the minimum viable project size doesn't align with disease prevalence. You're not trying to run an underpowered study—you're working with literally all the available patients who meet your criteria. The CRO's minimum sample requirements are forcing artificial constraints on scientifically valid research.

Speed Matters for Strategic Influence

Patient foundations aren't just generating data for publications. You're trying to influence clinical trial design, attract pharma partners, and shape regulatory strategy while therapeutic windows are still open. When a company is designing their Phase 2 trial and you have biomarker data that could improve patient selection, timing matters.

A four-month turnaround for bioanalysis means you miss key decision points. By the time you have results, the trial protocol is locked, the partnership discussion has moved on, or a competing approach has taken priority. Speed isn't about impatience—it's about being able to participate in decisions while they're still being made.

This is particularly critical for registry studies and natural history data. If you're demonstrating that a particular biomarker correlates with disease progression, that information is most valuable when companies are selecting endpoints for their trials. Getting that data quickly enough to influence trial design creates exponentially more value than publishing the same findings after trials are already underway.

Financial Constraints Are Real

Foundations operate with different economics than pharmaceutical companies. You're accountable to donors, often working with constrained budgets, and trying to maximize impact across multiple research initiatives. A $500K bioanalysis project might represent a significant portion of your annual research budget, which means you need to be confident in the value before committing.

Traditional CROs don't make this easy. Pricing often comes with caveats, change orders appear mid-project, and scope creep is common. You start with a quote for method development and validation, then discover additional costs for repeat analysis, data queries, or documentation. By the time the project is done, you've spent 40% more than the initial estimate.

We price everything upfront because we understand you can't go back to your board or donors and ask for more funding because a CRO underestimated their costs. You need to know the complete project cost before you commit, and you need that number to be reliable.

The Strategic Value of Accessible Bioanalysis

Having access to fast, affordable bioanalysis changes what's possible strategically. You can test biomarker hypotheses before committing to large natural history studies. You can generate preliminary data to attract pharma partnerships. You can validate endpoints that make your disease area more attractive for drug development.

Consider a common scenario: a pharmaceutical company is evaluating your disease area for a clinical program, but they're concerned about endpoint sensitivity. If you can quickly generate biomarker data from your registry showing a measurable, drug-responsive signal, you've made their decision easier. But if generating that data takes six months and requires enrollment numbers you don't have, the opportunity passes.

Or another situation: you're running a natural history study and samples are coming in steadily over time. Traditional CROs want to batch everything and run analysis once you hit their minimum threshold. But batching means your early enrollees' samples sit in a freezer for months, and you can't share any preliminary findings with potential partners. Being able to analyze samples as they arrive, in groups as small as 30, means you're generating insights continuously rather than waiting for arbitrary volume thresholds.

GLP Compliance Without the Pharma Overhead

Patient foundations need data that meets regulatory standards. Whether you're supporting an IND filing for an investigator-initiated trial or trying to influence FDA endpoint selection, your bioanalysis needs to be defensible to regulators. This means GLP compliance—documented procedures, validated methods, proper instrument qualification, complete audit trails.

The challenge is that GLP compliance at traditional CROs comes bundled with pharma-scale overhead. You get assigned a team sized for a 2,000-patient study when you have 50 samples. You're paying for organizational infrastructure built around pharmaceutical sponsors with different needs and much larger budgets.

We run full GLP, but our operational model is built around the project sizes foundations actually need. You get the same regulatory rigor without paying for excess capacity. The documentation packages we provide meet the same standards used in IND filings—we've just removed the unnecessary overhead that comes from treating every project like a pivotal trial.

Investigator-Initiated Trials Need Different Economics

Many patient foundations support investigator-initiated trials—academic collaborations testing new therapeutic approaches or repurposed drugs. These trials often have constrained budgets and tight timelines, but they still need GLP-compliant bioanalysis to support regulatory submissions.

Traditional CRO pricing assumes a pharmaceutical sponsor who's already invested hundreds of millions in the program. For an investigator-initiated trial running on foundation funding or academic grants, those economics don't work. The bioanalysis costs can become a barrier to running scientifically important trials.

We've priced our services to make investigator-initiated trials feasible. The same GLP compliance, the same quality standards, but at a price point that fits within academic collaboration budgets. This means more trials can move forward, more therapeutic approaches get tested, and foundations can support clinical research without bioanalysis costs consuming their entire budget.

What This Looks Like in Practice

A foundation reaches out with samples from 35 patients in their natural history study. They need to quantify a protein biomarker to understand whether it correlates with disease progression. Traditional CROs either won't take the project or quote timelines that don't help their strategic goals.

We provide a complete quote within 48 hours: method development cost, validation cost, per-sample analysis pricing. Total timeline is 8 weeks from kickoff to final report. The foundation knows exactly what they're spending and when they'll have data. They can plan the rest of their research strategy around reliable delivery.

Three months later, they have GLP-compliant results showing their biomarker correlates with clinical outcomes. They're in active discussions with two pharmaceutical companies about potential trials, and the biomarker data is directly informing endpoint selection. The speed of delivery meant they could influence trial design rather than just publishing findings after trials were already running.

That's the difference accessible bioanalysis makes—not just having data, but having it when it creates strategic value.

Starting a Project

If you're running a registry, natural history study, biomarker qualification project, or investigator-initiated trial, send us your study details. We'll provide a detailed quote within 48 hours showing complete costs and timeline. You'll know exactly what the project costs before you commit, and you'll have data in weeks rather than months.