AI-Powered Clinical Development

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

AWS Startup ProgramsHiHarvardinnovation labsGoogle for Startups
Why AIRA

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

Trust Infrastructure

Designed for regulated environments.

SOC 2 Type IIISO 27001HIPAA-readyGDPRGxP-aligned workflowsNo AI training on any confidential data

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.

How It Works

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.

Study context graphs

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.

Structured document drafting

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.

Risk surfacing

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.

Connected knowledge workspace

“Working with AIRA feels like having an extra team of experts at the table with us for every decision and action”

ALC

VP of Clinical Development, Biotech

Solutions

Built for every clinical team working on bringing treatments to patients faster and safer.

From the Field

What our clients say

I started preparing for our meetings in AIRA by reviewing its insights, asking questions from it in advance so we start the meeting by discussing AIRA’s suggestions

MKT

Scientific Strategy Lead

Biotech

We use AIRA so we can prepare the first draft of the protocol and discuss our clinical strategy internally and only engage CROs later

JR

CEO

Biotech

So many times, we don’t know what we don’t know, so I will personally make sure that everyone on the team reviews AIRA insights relevant to them

DW

Senior Regulatory & Development Expert

Biotech

AIRA’s insights are really valuable, and the drafting with our template saves a lot of time. Also, I could use AIRA to generate a draft of the consent form for the study in minutes

NB

Principal Investigator

Cancer Center

I started preparing for our meetings in AIRA by reviewing its insights, asking questions from it in advance so we start the meeting by discussing AIRA’s suggestions

MKT

Scientific Strategy Lead

Biotech

We use AIRA so we can prepare the first draft of the protocol and discuss our clinical strategy internally and only engage CROs later

JR

CEO

Biotech

So many times, we don’t know what we don’t know, so I will personally make sure that everyone on the team reviews AIRA insights relevant to them

DW

Senior Regulatory & Development Expert

Biotech

AIRA’s insights are really valuable, and the drafting with our template saves a lot of time. Also, I could use AIRA to generate a draft of the consent form for the study in minutes

NB

Principal Investigator

Cancer Center

Get Started

Join the growing community of biopharma teams using AIRA to move faster, reduce costs, and bring therapies to patients sooner.

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40%

Faster submission cycle

$150K to millions

Saved per study

From 4-6 weeks

Faster protocol development

50%

Less amendments

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