Clinical Trial
Documentation
Done Right
AI agents that plug into your study lifecycle, from protocol quality gate through audit readiness, so your team spends time on science, not document management.
Protocol gaps caught before submission, not during review.
TMF continuously audit-ready. Not just before inspection day.
Time to first POC on your own documents.
What Clinical Teams
Deal With Every Day
Protocol Gaps Found Too Late
IRB-blocking issues discovered at review. Rework delays the entire study timeline.
Misaligned Documents
Protocol, consent, and recruitment drafted separately. Inconsistencies caught by IRB, not your team.
Missed Amendment Impacts
Protocol changes don't automatically cascade. Version mismatches surface at audit.
TMF Always Behind
Wrong dates, wrong names extracted from GCP certificates. Manual correction before every upload. Never truly inspection-ready until the week before audit.
Audit Prep Is a Fire Drill
Document history reconstructed from emails and shared folders. Evidence scattered, versions unclear.
Institutional Knowledge Is Fragile
Protocol drafting depends on whoever has done it before. When they leave, the knowledge leaves too.
Not a Copilot.
Agentic Operations.
Chatbots
Answer questions. Nothing more. You still do all the work.
Copilots
Draft content, suggest edits. You complete every action manually.
Agentic Operations
Execute complete workflows end-to-end. Policy guardrails, full audit trails, human-in-the-loop only for exceptions.
Study Lifecycle.
Agent by Agent.
Drafting from scratch. Inconsistent section structures. Institutional knowledge lost when writers move on.
Approved language and section structures surfaced from your own study library.
IRB-blocking gaps in ethical signals, risk clarity, eligibility found during review. Rework is expensive at that stage.
Standardised protocol audit. IRB-required sections, ethical signals, severity-classified findings.
Different teams, different timelines. Eligibility drift, missing disclosures, wrong audience tone. IRB catches it, not you.
Protocol as canonical source. Cross-checks consent and recruitment at section level.
An eligibility change cascades into consent, recruitment, IB. Downstream docs missed. Version mismatches at audit.
Meaning-level change detection via knowledge graph. Flags every document requiring update.
Wrong dates, wrong names, missing roles extracted from GCP certificates. Every record corrected manually before upload.
Multi-model OCR, confidence-scored per field. Structured output pushed directly to your eTMF.
Every agent output is evidence-backed, version-stamped, traceable. Inspection readiness is a byproduct of the workflow, not a separate effort.
Connects Into
Your Systems
Three patterns. All enterprise-grade. Zero disruption. Applies across all five agents.
Scheduled Pull and Push
On-demand or scheduled. Fetches documents, processes via agent, returns structured output.
Real-Time Event-Driven
Document upload or state change triggers the agent. Output pushed back instantly.
Azure Logic Apps
Orchestration layer with transformation, validation, and business rules before output is returned.
POC on
your documents.
Pick your challenge. TMF accuracy, protocol review, document alignment. We'll have something running in days.
Get in touch with us.
We're here to assist you.
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