The new era in clinical development
Join the growing number of biopharma teams that trust AIRA to move faster, avoid costly mistakes, and make defensible study design decisions.
Supported by
AIRA is a unified AI platform for study design and protocol development
At its core, AIRA is the only AI platform where your team collaborates with built-in expert-level clinical, regulatory, and medical writing AI thought partners that pay attention to your continuously evolving study context and develop it with you.
40% faster submission cycle
Save $150K+ to millions per study
Prevent up to 50% of amendments
Collaborate without chaos
Make confident, defensible decisions
From protocol drafting to regulatory risk flags — see how AIRA brings expert-grade intelligence to your entire clinical development workflow.
Designed for regulated environments.
Security and compliance are embedded in the architecture - not added later. They define how we build our technical core, design our processes, and grow our organization.
What our clients say
Dr. Ilonna Rimm
Pediatric Oncologist & Investor, Oncology Biotech
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. I find AIRA extremely valuable because it allows teams to access and evaluate design pathways and options based on their strategic goals and constraints, understand trade-offs, and develop the regulatory submission package more accurately and quickly.
András Málnási-Csizmadia
Founder, PeriFlow Therapeutics
David Harrington, PhD
Prof. Emeritus of Biostatistics, Harvard Chan School · Former Lead Statistical Editor, NEJM
Marc Debelle
Pharmaceutical Drug Development Consultant
Sándor
VRG Therapeutics
Zalán Péterfi
VRG Therapeutics
Dr. Ilonna Rimm
Pediatric Oncologist & Investor, Oncology Biotech
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. I find AIRA extremely valuable because it allows teams to access and evaluate design pathways and options based on their strategic goals and constraints, understand trade-offs, and develop the regulatory submission package more accurately and quickly.
András Málnási-Csizmadia
Founder, PeriFlow Therapeutics
David Harrington, PhD
Prof. Emeritus of Biostatistics, Harvard Chan School · Former Lead Statistical Editor, NEJM
Marc Debelle
Pharmaceutical Drug Development Consultant
Sándor
VRG Therapeutics
Zalán Péterfi
VRG Therapeutics
Platform Capabilities
INTELLIGENCE
Provides clinical trial intelligence grounded in traceable evidence and expert reasoning
- Analyzes any question in full study context
- Applies built-in expert-grade clinical and regulatory reasoning
- Grounds answers in guidelines, precedents, and curated data, with clear references and an explained chain of thought
- Proactively adds insights and considerations to the discussion
- Recommends concrete next steps
Why it matters: Save hundreds of hours of research. Transform scattered information into actionable, study-specific insights. Make evidence-backed decisions you can confidently defend to regulators.
AUTHORING
Develops compliant study document drafts and implements changes
- Generates protocol drafts
- Suggests improvements and next steps as your study evolves
- When you instruct AIRA to make changes, it asks clarifying questions, identifies, and explains the downstream implications
- Implements changes across affected sections with medical writing expertise and with full traceability
Why it matters: Save weeks in protocol development. Maintain consistency across documents. Prevent avoidable amendments. Shift your team’s time from writing to strategic decision-making.
INSIGHTS AND REVIEW
Provides evidence-backed recommendations and reviews your documents with actionable guidance
- Runs continuous regulatory and feasibility checks based on expert best practices
- Flags regulatory risks, gaps, and optimization opportunities
- Recommends clear resolutions
- Allows you to run your organizational review playbooks
Why it matters: Catch regulatory and feasibility issues early to avoid amendments and submission delays. Strengthen strategic and regulatory alignment across your study design. Move from an external expert-first to an evidence-first study design.
CONTEXT AWARENESS
Connects and synthesizes evolving study information to suggest next steps, convert information into action, and prevent misalignment
- Tracks all documents, discussions, and study updates
- Connects information across drafts, comments, and research to help you formulate decisions
- Flags inconsistencies and misalignment
- Converts uploaded meeting notes into actionable next steps
Why it matters: Save days by turning static information into immediate next steps. Reduce back-and-forth and internal rework. Eliminate scattered information and preserve decision rationale.
“AIRA took us from the earliest strategic planning all the way through drafting the actual documents — all in one place. We’re planning to keep using it as we move into our next phases.”
András Málnási-Csizmadia
Founder, PeriFlow Therapeutics
Built for every clinical team working on bringing treatments to patients faster and safer.
Join the growing community of biopharma teams using AIRA to move faster, reduce costs, and bring therapies to patients sooner.
Get early access, product updates, and clinical development insights delivered to your inbox.
Subscribe to our newsletter
40%
Faster submission cycle
$150K to millions
Saved per study
From 4-6 weeks
Faster protocol development
50%
Less amendments