TriClick™ Documentation

Core Tool

TriClick™ Stats

Stats is the statistical programming engine — the tool most teams meet first. It reads raw data and specifications, generates SDTM datasets, derives ADaM, and produces the Tables, Listings, and Figures, with traceability back to the SAP throughout.

What it produces

• ·SDTM datasets generated from raw study data and specifications
• ·ADaM datasets derived from SDTM
• ·Tables, Listings, and Figures as R or SAS code, plus the rendered, filled-in outputs
• ·Full SAP traceability across generated outputs

Review before QC

Before anything reaches formal QC, finished outputs go through an AI pre-review that returns structured, severity-ranked findings. The programmer resolves the obvious issues before a human reviewer ever opens the file — which is where most of the QC ping-pong cycle usually goes.

Reproducibility

• ·Pinned, validated environment. Code that produced a TLF this month produces the same TLF when re-run later.
• ·Auto-versioned outputs. Every result is traceable to who ran it, when, and how.
• ·GCP-ready, audit-defensible artifacts by default.

Core Tool

TriClick™ Annotation

Produces CDISC-compliant annotated Case Report Forms for FDA submissions. Annotation is repetitive, easy to do inconsistently, and unforgiving when it goes wrong — Annotation applies the mapping uniformly across the form set and keeps it consistent as the study evolves.

• ·CDISC-compliant annotated CRFs ready for submission
• ·Consistent mapping across the full form set
• ·Reduces the regulatory risk that comes from manual annotation drift

Core Tool

TriClick™ Compliance

Handles the de-identification side of clinical data. Compliance desensitizes and anonymizes medical information to meet HIPAA, GDPR, and FDA requirements while preserving enough structure for the data to remain analytically useful.

• ·Automated de-identification and anonymization of medical information
• ·Data utility preserved for downstream analysis
• ·Dataset validation against SDTM and ADaM standards
• ·CDISC validation applied throughout the workflow, not only at the end

Core Tool

TriClick™ Evidence

Extracts clinical insight from unstructured sources — trial records, published literature, and regulatory filings — and turns them into evidence summaries that support clinical and regulatory decisions.

• ·Extraction across trial records, literature, and regulatory filings
• ·Real-time evidence summaries for clinical and regulatory decisions

Data Management Agent — Protocol-to-CRF

The Data Management Agent starts further upstream than the rest of the platform. It takes a study protocol and turns it into a structured first-draft CRF, so the form design conversation starts from a draft rather than a blank page.

What it extracts

Visits, assessments, the schedule of activities, eligibility criteria, safety requirements, dosing, and follow-up requirements.

How review works

• ·Every generated field links back to its source evidence in the protocol
• ·Reviewers leave field-level comments; the agent returns revision proposals with before/after comparisons for human approval
• ·Protocol language is auto-detected, and the CRF display language can be set separately

Exports

CRF document, eCRF draft, and the schedule-of-activities matrix, for downstream review.

VS Code Extension — The Last Mile

TriClick generates the study code. The expensive part — reviewing it, correcting it, and signing it off — stays with your statistical programmers, and the extension lets them do that work in the VS Code they already use rather than in someone else's tool.

How it works

• ·TriClick generates the code. SDTM, ADaM, and TLF programs, ready to open in VS Code.
• ·You own the last mile. Review, correct, and finalize in your own editor; scientific review and final approval stay with your team.
• ·Bring your own AI. Point your team's local AI coding agents at the code, right alongside it.
• ·Nothing is lost. Edits sync back with full version history, tagged human or agent, without leaving TriClick's versioning and audit trail.
• ·Regenerate in-platform. Revise derivations, then regenerate outputs from the platform.

Teams running TriClick as licensed software operate it through both surfaces — the web app and the VS Code extension.

Submission Documents

Datasets are only part of a filing. TriClick generates the reviewer-facing documents that accompany them:

• ·ADRG — Analysis Data Reviewer's Guide
• ·SDRG — Study Data Reviewer's Guide
• ·Define.xml — dataset metadata definition

Audit & Traceability

The platform is built on the assumption that generated output has to survive QC, handoff, and audit prep. Three features carry that weight.

Audit Package

Delivered alongside the datasets and TLFs as a customer-facing artifact:

• ·Review dashboard
• ·Evidence manifest
• ·Audit graph
• ·Execution trace
• ·Review packet
• ·Prioritized worklist

Lineage Graph

Traces the path from study inputs to final deliverables — source data, specifications, CRFs, shells, intermediate decisions, generated code, checks performed, and final outputs.

Transparent reasoning

For every supported output, the platform exposes the source evidence used, intermediate artifacts, assumptions made, checks performed, and current review status.

Reference

AI Capabilities

The specialised capabilities underlying the four core tools:

• ·LLM-Augmented Clinical Analytics System
• ·CRF Annotation Agent
• ·Data Compliance Agent
• ·Evidence Summary Tool
• ·Data Reverse Engineering
• ·Relational Information Extraction
• ·Biometrics & Secure Data Platform

Reference

Standards & Compliance

• ·CDISC — SDTM and ADaM validation built into the workflow
• ·21 CFR Part 11 — designed to meet electronic records and signatures requirements
• ·HIPAA and GDPR — patient data protection through automated de-identification
• ·GCP-ready — audit-defensible, auto-versioned outputs

Reference

Access & Plans

Self-serve individual plans — TriClick Go, Plus, and Pro — let biostatisticians, programmers, and clinical scientists evaluate the platform on real workflows without a procurement cycle. Plans are metered in table credits, with shared projects, audit logs, and governed exports at the higher tiers.

Team, department, CRO, and pharma sponsor rollouts — including custom pricing, volume credits, SSO, and dedicated onboarding — are handled directly.