10 Patients Randomized. $3,000 Per Randomized Patient.
Blue Lake Biotechnology's Pediatric RSV Vaccine study reached its randomization target through a targeted, IRB-compliant campaign, with accountability for every patient enrolled.
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Patients Randomized
$30,000
Campaign Investment
$3,000
Cost Per Randomized Patient
Sponsor
Blue Lake Biotechnology Inc.
Vaccine candidate
BLB-201 (intranasal, PIV5-vectored RSV vaccine)
Phase
1/2a
Enrolled population
Infants and children, 6 months to 5 years, RSV seronegative and seropositive
Full study enrollment target
137 participants
Site profile
3 site locations (multi-site engagement)
Registration
NCT05655182 on ClinicalTrials.gov
Biotech Enrollment Timelines Don't Have Contingency
For biotech sponsors running their own study sites or working with early-phase CROs, enrollment timelines are tied directly to capital runway. A study running 90 days behind enrollment projections is not just a clinical problem. It is a financing problem. Investors track milestones. Delayed data readouts push reporting windows. The cost of slow enrollment in a capital-constrained biotech environment is measured in more than coordinator hours.
Blue Lake Biotechnology's Pediatric RSV Vaccine study needed patients enrolled within a defined window. The internal resources available for patient outreach were limited by the organization's operational scale. Developing IRB-ready campaign materials, establishing media placements, and managing pre-screening logistics required infrastructure that was not available in-house.
The alternative: engaging a traditional recruitment vendor with fees payable regardless of randomization outcomes. For a biotech operating with budget discipline, that structure was not acceptable.
Built for the Protocol. Committed to the Outcome.
Clinical Enroll evaluated Blue Lake Biotechnology's Pediatric RSV Vaccine protocol for feasibility before any campaign work began. Feasibility determined whether the randomization commitment was supportable given the protocol's criteria, the available patient population, and the campaign budget. The commitment was extended and formalized in contract. An IRB-compliant campaign was built and deployed, with pre-screening integrated into the referral process before any patient reached the site team.
10 Randomized Patients. $3,000 Per Patient.
The campaign delivered 10 randomized patients against a $30,000 investment, a cost per randomized patient of $3,000.
Per-patient site fees for pediatric vaccine studies vary by protocol structure and phase. At an estimated $3,000 to $10,000 per-patient site fee, 10 randomized patients represents a potential $30,000 to $100,000 in patient revenue against a $30,000 campaign investment.
The randomization commitment meant Blue Lake Biotechnology's recruitment budget was tied to a defined outcome, not an activity report. For a capital-disciplined organization, that distinction carries material weight at the budget approval level.
POTENTIAL ROI
$30,000
Campaign investment
$3k-$10k
Per-patient site fee range
$30k-$100k
Potential patient revenue
How Feasibility Was Verified Before Launch
Clinical Enroll evaluated the BLB-201 protocol for feasibility before extending a randomization commitment. The review modeled the addressable pediatric population, accounted for RSV serostatus requirements, and mapped consent logistics for a study where parents and guardians, not the participants, are the decision-makers. Feasibility confirmed a viable pipeline across three site locations, structured against the study's 137-participant enrollment target.
- Protocol and eligibility review — study criteria verified against the registered protocol, NCT05655182.
- Addressable population modeling — pediatric patient density and consent logistics assessed within each site's catchment area.
- IRB-ready campaign build — condition-targeted creative and channels developed for compliance review.
- Pre-screening — every referral is screened against the study's inclusion and exclusion criteria before reaching the site.
- Contracted randomization commitment — the enrollment target is fixed in writing before the campaign launches.
Read more about how Clinical Enroll runs feasibility assessments before every engagement.
Common questions about this engagement.
See if our guaranteed approach is the right fit for your study.
Book a free consultation to walk through your protocol and enrollment goals. We will tell you whether our guaranteed recruitment model fits your study before you commit anything.
All campaigns developed for IRB review and deployed in accordance with FDA guidance on clinical trial advertising.