Context AI/
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

Numbers are retyped, not referenced

Writers transcribe results from about 150 TLFs into Sections 10–12 and build summary tables by hand.
Transcription errors surface at QC or regulatory review- rework after every TLF rerun.

Consistency is checked by reading

Synopsis, body, Section 14, protocol, SAP, ADaM and SDTM are compared manually.
Mismatches such as randomised N between synopsis and disposition reach final review.

Changes are invisible

Protocol amendments, SAP updates and TLF reruns arrive without a record of which CSR text depends on them.
Outdated text survives into the final CSR- late re-review cycles.

No audit-ready trail

Reviewers and auditors cannot see where a statement came from or how AI was used.
Low trust in AI-assisted text- slower sign-off; inspection exposure.

Key Capabilities

Agent Capabilities

Six agents run in a fixed, gated order: Study Intelligence/Definitions → Discovery → Readiness → Evidence → Section Authoring → QC / Compliance. Five human-in-the-loop gates.
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Automatically detects protocol amendments and flags which consent sections require updates - preventing outdated consent from reaching participants and reducing compliance risk.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

Measurable Outcomes

These are design targets, benchmarked against published industry results. They will be confirmed on pilot CSRs.

2–3 Weeks → 3–5 Days

30-50% Faster consent drafting and approval cycles

~180 → 80–100 Hours

30-50% Improvement in participant comprehension and readability scores

100%

30-50% Reduction in consent deviations and inconsistencies

6 Agents · 5 Gates

Improved Regulatory readiness and audit traceability across all studies

Our Solutions

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Blogs

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