Clinical evidence for the science *behind the science*

You’ve built the novel delivery system, the proprietary compound, the breakthrough platform. Now you need the clinical data that turns IP into investor confidence, regulatory readiness, and commercial partnerships.

How does Citruslabs run studies for Biotech & Pharma? Citruslabs designs and runs IRB-approved clinical studies tailored to Biotech & Pharma brands — consumer perception studies (4–8 weeks, $15K+), single-arm clinical studies (8–12 weeks, $40K+), or randomized controlled trials (12–16 weeks, $80K+). Each study uses category-appropriate endpoints and biomarkers, ships with a marketing claims appendix reviewed for FTC and FDA best practices, and earns the optional Citruslabs Tested Seal if the data supports product claims.

Clinical evidence for biotech innovations — from novel delivery systems to precision nutrition platforms.

Traditional CROs aren’t built for *biotech innovators*

You’re not a pharma company with a 200-person clinical ops team and a 3-year timeline. You’re a biotech startup or scale-up with a novel technology, a tight runway, and investors who need data — not excuses about enrollment delays. **Legacy CROs charge enterprise prices, move slowly, and treat every study like a Phase III drug trial.** You need a CRO that understands the difference between regulatory validation and commercial evidence — and knows how to deliver both, fast.

Timeline: 12–24 months | Cost: $500K–$2M+ | Recruitment: Outsourced | Communication: Monthly calls | Flexibility: Change orders

Timeline: 8–16 weeks | Cost: 70–85% less | Recruitment: 250K+ database | Communication: Slack / real-time | Flexibility: Iterative

Categories

Study Types

Frequently Asked Questions

Does my product need to be FDA-approved to run a clinical trial?

No. Most consumer biotech products — supplements, functional foods, delivery technologies, and wellness platforms — don’t require FDA approval to run a clinical trial. Our studies operate under IRB oversight and are designed for commercial evidence, marketing claims, IP support, and publication. If you’re pursuing an FDA regulatory pathway (e.g., GRAS, NDI, or De Novo for devices), we can design studies that generate data aligned with those requirements.

Can clinical trial data support patent filings?

Yes, and this is one of the most valuable use cases for biotech companies. Clinical data proving unique efficacy, superior bioavailability, novel mechanisms, or specific dosage-response relationships can significantly strengthen patent applications. We’ve worked with IP attorneys to ensure study designs generate the specific data points needed for claims of novelty and non-obviousness.

How is a biotech trial different from a supplement trial?

Biotech trials typically require more complex study designs — head-to-head comparisons, pharmacokinetic blood draws, multi-cohort stratification, and mechanistic biomarkers beyond standard health panels. The audience for the data is also different: investors, regulatory bodies, and scientific publications vs. primarily marketing and retail. We scale our methodology to match the rigor your stakeholders expect.

What study designs do you support?

We support randomized controlled trials (RCTs), crossover studies, head-to-head comparisons, single-group pre/post designs, and observational real-world evidence studies. For biotech clients, we most commonly run placebo-controlled RCTs (the gold standard for publication and investor presentations) and head-to-head PK studies for delivery technology comparisons.

Do I own the data and IP from my study?

Yes, 100%. You retain full ownership of all raw data, statistical analyses, study reports, and any resulting intellectual property. You can use the data in investor materials, patent filings, marketing, scientific publications, and regulatory submissions. We have no claim to your study data or any IP derived from it.

How fast can a biotech study be completed?

Most biotech studies run 10–20 weeks from kickoff to final deliverables, depending on complexity. Simple PK studies can finish in 8–10 weeks. Complex multi-arm RCTs with blood panels and multi-site enrollment may take 16–20 weeks. That’s still 3–5× faster than a traditional CRO, largely because of our decentralized infrastructure and participant database of hundreds of thousands that eliminates the recruitment bottleneck.

Testimonials

We needed pharmacokinetic data to prove our liposomal delivery was actually superior. Citruslabs designed the head-to-head, recruited 120 participants, and delivered a data package that closed our Series A.

Kevin Park, CEO & Co-Founder

The speed difference vs. our previous CRO was staggering. What would have taken 18 months was done in 14 weeks. And we communicated over Slack instead of waiting for monthly status calls.

Sarah Levine, VP Clinical Operations

We used the clinical data to strengthen two patent filings for our novel compound. Our IP attorney said it was the most useful efficacy data he’d seen from a CRO study. It directly supported our claims of mechanism.

David Reyes, Chief Science Officer