AIRA Health, a company originating from Harvard Innovation Labs, closed a pre-seed round of nearly $2 million. The company is also announcing the launch of Colligo, an AI-powered platform for clinical trial design and protocol development.
Colligo brings together biopharma teams and CROs with specialized AI agents acting as thought partners across clinical strategy, regulatory intelligence, biostatistics, and medical writing, enabling teams to save $150K-$1M+ per trial, cut development timelines by 40%, and prevent avoidable amendments that delay patient access to new therapies.
The Problem: Growing Costs, Manual, Error-Prone Process
Designing early-phase clinical trials today takes 6-12 months and costs hundreds of thousands to millions of dollars in expert costs, yet the process remains largely manual, siloed, and prone to errors. According to the Tufts Center for the Study of Drug Development, most clinical studies undergo multiple protocol amendments, and nearly half of those amendments are avoidable, each one costing an average of $400,000 in direct costs alone.
AIRA's Solution: Collaborative AI Platform Augmenting Human Expert Work
Colligo is not a standalone AI chatbot or document-drafting engine. In Colligo, specialized AI agents pay attention to the evolving study context and develop it with the teams, from initial evidence-backed program strategy and design iterations through submission-ready documents by surfacing regulatory precedents, recommending development pathways and trial design alternatives, explaining trade-offs, flagging feasibility risks, and keeping stakeholders aligned.
When a clinical development team evaluates a key design decision — such as endpoint selection or statistical methods — Colligo surfaces context-specific, evidence-based options, analyzes relevant precedents, and highlights feasibility, regulatory, and operational implications. Changes are reflected not only in regulatory documents such as the protocol, SAP, or IB, but also in their implications for the overall trial design and clinical development plan — all within a single workspace and with full human oversight.
Proven Results
The platform has been validated through collaborations with U.S. biotech companies spanning preclinical through Phase 3 across oncology and other therapeutic areas, as well as with leading cancer centers. Partner teams reported:
- 40-50% shorter protocol development cycles
- First-draft timelines reduced from weeks to days
- Hundreds of hours of expert work saved
- $150K to $1.2M+ savings per trial
"We are building AIRA with the mindset that a new technology only matters if it leads to improved safety alongside efficiency, not just the latter," said Levente Fazekas, CEO of AIRA Health. "I believe every clinical development team will be using platforms like ours within the next few years. The question is no longer whether AI will reshape clinical development, but how quickly teams will adopt it."
Industry Feedback
"Trial design and protocol development need to be improved from both the biotech and the investor perspectives. Protocol development is a critical but challenging process due to its complexity, rapid changes in the regulatory and treatment environment, and the constraints biotechs are facing," said Dr. Ilonna Rimm, a pediatric oncologist with 20+ years of experience working on clinical trials and now an investor in multiple oncology biotech companies. "I find AIRA extremely valuable because it allows teams to access and evaluate design pathways and options, understand trade-offs, and develop the regulatory submission package more accurately and quickly."
Market Context
The launch comes as the biopharma industry faces mounting pressure to run more efficient, cost-effective trials. While AI adoption is accelerating across drug development, most tools focus on isolated tasks. AIRA introduces a new category: a collaborative decision platform that brings clinical development workflows and expert intelligence into a single AI-powered system.
"Potential clients all faced similar challenges, and they clearly liked the solution. That's why we believe AIRA has an exciting future ahead," said Laszlo Czirjak, managing partner at Interactive Venture Partners. "The company solves a real problem. They're targeting a large market while reducing costs for clients and helping them generate revenue faster."
AIRA Health is a Boston-based technology company building the decision infrastructure for modern clinical development. Its platform, Colligo, is a unified system for study design and protocol development, where biopharma teams collaborate with AI agents across clinical, regulatory, biostatistical, and medical writing domains.
Unlike traditional tools focused on research or document automation, AIRA supports the full decision-making process behind trial design, helping teams evaluate trade-offs, align across stakeholders, and develop higher-quality, execution-ready protocols.
Originating from the Harvard Innovation Labs ecosystem and developed in collaboration with industry partners and leading experts from Dana-Farber and Harvard, AIRA’s early collaborations have shown measurable impact, including ~40% faster timelines, up to 50% fewer amendments, and savings of $150K to $1.2M+ per trial. By improving compliance, speed, and decision quality, AIRA helps bring new therapies to patients faster.
AIRA is backed by Interactive Venture Partners, Nesprit, and other specialist investors. In 2026, AIRA Health closed a close to $2 million pre-seed funding round.
For more information, visit https://www.aira.healthcare or https://www.linkedin.com/company/aira-health
