Context AI/
Protocol Digitization Agent
Transforming unstructured protocols into USDM-ready study definitions
An AI-powered co-pilot designed to accelerate protocol digitization and study definition creation by transforming fragmented clinical trial documents into validated, CDISC USDM-compliant structured data. Combines AI-driven document ingestion, structured data modeling, and automated conformance validation to enable faster, scalable, and compliant study setup.
90%
Faster protocol digitization
60–70%
Faster amendment processing
40–50%
Faster eCRF build cycles
Zero
Redundant manual study setup
What We Do
Challenges We Solve
Clinical organisations face significant inefficiencies and risks in protocol-driven study execution. Five critical pain points drive escalating timelines, compliance risk, and redundant effort.
1. Commercial AI
1. Commercial AI
1. Commercial AI
Sales operations agent
Market access agent
Marketing Intelligence Agent
Market Affairs agent
Manual digitization
Weeks of effort per study to manually interpret and re-enter protocol data — highly error-prone and non-scalable.
Fragmented protocol data
Protocols, SoA, SAP, and ICF exist across disconnected formats, making consistent structured extraction unreliable.
Amendment rework
No automated impact tracking means every protocol amendment triggers manual updates across EDC, RBQM, and ICF.
Late CDISC conformance
Validation happens at the end of the process, surfacing audit and submission risks far too late to fix efficiently.
Non-scalable study builds
EDC, RBQM, and IRT setups are rebuilt from scratch for every study, with no reuse of structured protocol definitions.
Key Capabilities
Agent Capabilities
Protocol Digitization Co-Pilot delivers ten integrated capabilities across the protocol-to-study-definition lifecycle.
1. Commercial AI
1. Commercial AI
1. Commercial AI
Sales operations agent
Market access agent
Marketing Intelligence Agent
Market Affairs agent
AI-Driven Protocol Intelligence
Automates ingestion, classification, and parsing of unstructured protocol documents into structured data.
CDISC Section Mapping
Maps extracted content into standardised CDISC taxonomy automatically, ready for downstream use.
Study Metadata Extraction
Extracts study design, arms, endpoints, visits, and schedules from raw protocol documents.
SoA Structuring Engine
Converts Schedule of Activities into canonical Epoch → Visit → Activity → Procedure hierarchy.
USDM Object Builder
Creates fully compliant, machine-readable CDISC USDM study definitions from ingested protocol content.
Controlled Terminology Alignment
Maps sponsor-specific terms to CDISC CT and manages non-standard extensions systematically.
Conformance Validation Engine
Executes CDISC CORE rules with automated findings during authoring — not at submission.
Amendment Intelligence Engine
Detects protocol change deltas and automates downstream impact propagation across all connected systems.
Review-by-Exception Workflow
SMEs validate only low-confidence AI outputs, reducing review time while maintaining quality control.
Downstream Automation
Auto-generates eCRF shells, RBQM configurations, ICF drafts, visit schedules, and eSource workflows.
Business Outcomes
Measurable Outcomes
Organisations deploying Protocol Digitization Co-Pilot achieve measurable improvements across the study build lifecycle.
Up to 90% faster protocol digitization — from weeks to hours
Reduced compliance risk through real-time CDISC conformance validation
60–70% faster amendment processing through automated delta detection and propagation
Elimination of redundant manual setup across EDC, RBQM, IRT, and ICF
40–50% faster eCRF build cycles via pre-built CRF shells from protocol definitions
Single source of truth: one USDM study definition driving all downstream systems
FAQs
Who is this solution built for?
Clinical operations, data management, and regulatory teams managing complex protocols, frequent amendments, and disconnected downstream systems across EDC, RBQM, IRT, and ICF.
Does it replace the clinical data manager?
No. The system is human-in-the-loop by design. AI processes and structures the protocol; clinical data managers validate, annotate, and approve all outputs.
What output formats does it produce?
USDM Study Definitions, Structured SoA, eCRF design shells, RBQM risk model configurations, ICF draft content, and visit schedule artefacts.
How does it handle protocol amendments?
The Amendment Intelligence Engine detects changes between protocol versions, generates a delta report, and propagates required updates to all downstream artefacts automatically.
Is CDISC CORE validation built in?
Yes. The Conformance Validation Engine executes CDISC CORE rules during the authoring process, surfacing findings in real-time rather than at submission review.
Accelerate Protocol Digitization with AI Agent
Enable faster, scalable, and compliant study setup with AI-driven protocol intelligence, automated conformance validation, and CDISC USDM-ready study definitions.

Our Solutions
We accelerate the delivery of therapies to patients through Gen AI enhanced industry solutions
Gene Inspector
REVOLUTIONIZE YOUR OMICS EXPERIMENTS WITH AI
Transform how researchers approach Omics experiments with accelerated biomarker discovery.

Biomarker Chatbot
UNLOCKING PRECISION MEDICINE WITH GEN AI
Streamline the discovery, analysis, and application of biomarkers in clinical research.

Gen Insights
Gen AI Powered Self Service Analytics Platform
Get relevant data insights faster and easier with our AI-driven decision intelligence platform.

Blogs
Insights & Resources
Similar Case Studies
Recent White Papers
Transform Your Clinical Operations
Partner with us to deliver faster, higher-quality clinical trials with technology that scales.








































.jpg)
.jpg)
.webp)

.webp)





.avif)
.avif)
