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Smart ICF Intelligent Agent

Smart ICF Intelligent Consent Form Agent

An AI-assisted solution for consent generation, validation, and lifecycle management that improves participant understanding, ensures protocol alignment, and maintains regulatory confidence - without increasing site burden.
30-50%
Faster consent drafting & approval cycles
30-50%
Improvement in participant comprehension
Improved
Regulatory readiness & audit traceability
Higher
Site confidence across global trials
What We Do

Challenges We Solve

1. Commercial AI
1. Commercial AI
1. Commercial AI

Complex and Difficult-to-Understand Consent Documents

Consent formsare routinely written in complex clinical and legal language that participantsstruggle to understand - undermining informed consent, increasing dropout risk,and creating regulatory vulnerability.

Manual Consent Drafting and Review Delays

Drafting consent documents from scratch for each study and amendment is a manual,time-intensive process that introduces delays, inconsistencies, and avoidable errors across sites.

Frequent Protocol Amendments Causing Consent Rework

Protocol changes frequently invalidate existing consent documents, triggering repeated drafting and review cycles that consume significant resources and delay trial progress.

Inconsistent Consent Language Across Studies and Regions

Without centralised governance, consent language varies across sites, studies, and countries - creating compliance risk and complicating regulatory submissions.

Limited Traceability Across Consent Versions and Approvals

Managing multiple consent versions across sites and amendments without automated tracking makes it difficult to demonstrate compliance and respond to audit queries.

Key Capabilities

Agent Capabilities

Smart ICF combines seven core capabilities that work together asan integrated consent generation, validation, and lifecycle managementplatform.
1. Commercial AI
1. Commercial AI
1. Commercial AI
Protocol-Aligned Consent Intelligence
Ensures that consent language is accurate, consistent, and fully aligned to the study protocol - automatically flagging mis matches between protocol requirements andconsent document content.
Plain-Language Optimization
Transforms complex clinical and legal language into clear, accessible content that improves participant comprehension and meets plain-language readability standards required by regulators.
Controlled AI-AssistedDrafting
Accelerates consent creation by generating protocol-aligned first drafts using approved templates and governed AI workflows - dramatically reducing manual authoring time.
Amendment Impact Awareness
Automatically detects protocol amendments and flags which consent sections require updates - preventing outdated consent from reaching participants and reducing compliance risk.
Key Capabilities

Your Competitive Edge

Technology that helps you win more bids and deliver exceptional results
30-50% Faster consent drafting and approval cycles
30-50% Improvement in participant comprehension and readability scores
30-50% Reduction in consent deviations and inconsistencies
Improved Regulatory readiness and audit traceability across all studies
Higher Site confidence and operational efficiency across global trials

Our Solutions

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Blogs

Insights & Resources

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Accelerate Informed Consent with AI Intelligence

Enable faster, compliant, and participant-friendly consent generation with AI-assisted drafting, plain-language optimization, and audit-ready lifecycle management.