Two weeks to a review-ready Phase 1 design. Two days to a protocol draft. Up to 90% less cost.
How PeriFlow Therapeutics reached a review-ready Phase 1 design in two weeks and a protocol draft in two days - replacing hundreds of thousands in external expert spend, and catching the design flaws that become six-figure amendments before they happened.
AIRA took us from the program strategy planning all the way through drafting the IND submission documents consistently in one place. It surfaced suggestions and issues we did not think of, putting everything into the context of our program. We're planning to keep using it as we move into our next phases.
- András Málnási-Csizmadia, Founder, PeriFlow Therapeutics
PeriFlow Therapeutics is a Boston-based biotech advancing a first-in-class treatment for capillary no-reflow after heart attack, a condition with no approved drug today.
Founder András Málnási-Csizmadia and CEO Mark Fraga aren't first-time biotech operators - they'd taken earlier programs through first-in-human design before and knew exactly what that path costs, in money, time, and risk. That's why, designing PeriFlow's own program, they went looking for something different.
A familiar problem for every lean biotech
If you're a lean biotech running clinical development in-house or heavily outsourcing, whatever phase you're in, this will be familiar.
The traditional path is slow and expensive.
Getting a trial design and protocol package review-ready usually means expensive internal hires or an extended engagement with external clinical, regulatory, biostatistics, and medical writing consultants. Study design and protocol development work alone typically runs $500K–$1.5M and takes 3–8 months, every day eating into runway.
Getting the strategy and the trial design right takes cross-functional expertise.
It needs clinical, regulatory, and biostatistics input on every decision, and each decision has to fit the larger clinical development plan, not just Phase 1 on its own. That’s hard to do well, even for experienced teams. Most AI tools in this space focus on writing documents faster, not making the decisions themselves better.
Amendments are common, expensive, and often avoidable.
Most trials face on average 3 protocol amendments; roughly half are avoidable, and each one adds close to $400K and about three months.
When PeriFlow evaluated their options, one thing mattered more than raw speed:
“AIRA gave us access to the quality of clinical, regulatory, and medical expertise that would otherwise have required several senior hires and hundreds of thousands of dollars before we could even get started.
For an early-stage biotech, that step-cost can become a catch-22, delaying development by a year or more while you raise the money needed to build the team. AIRA allowed us to move forward immediately, reduce future development risk, and produce work we were confident putting in front of external experts and investors.
Just as importantly, the AIRA team have approached the relationship as true partners.”
- Mark Fraga, CEO, PeriFlow Therapeutics
Strategy and Phase 1 design as one connected workflow
PeriFlow selected AIRA as its platform for trial design and protocol development. Key use cases:
Overall clinical development strategy
Spanning Phase 1 through registration, so early decisions support what comes later.
Phase 1 study design
Dose-escalation, endpoint, statistical, and regulatory strategy, worked in parallel.
Protocol and regulatory dossier drafting
Translating every design decision directly into document language.
Risk review and mitigation
Flagging amendment risks and design inconsistencies to prevent costly rework.
Outside experts were then engaged for a targeted review, not to build the design from scratch. That single shift is where most of the cost came out.
Traceability mattered most.
Change one decision, and AIRA summarized every downstream effect and drafted the edits needed to stay consistent - the exact place amendments and rework usually get born by hand.
A fraction of the traditional cost and timeline
PeriFlow reached a submission-ready protocol at a fraction of the traditional cost and timeline, with the risks that usually become amendments caught before they turned into six-figure problems.
Get Started
Ready to design your next trial, Phase 1 or later?
See how AIRA helps lean teams reach a review-ready design in days, at a fraction of the cost of a traditional expert-led path - and avoid the amendments that cost six figures and months each.
Book a 15-minute demo