TruForm – AI-Powered Clinical Data Transformation Platform
TruForm is an advanced AI-powered clinical data transformation platform developed by TruMinds Clinical to modernize and accelerate the clinical trial submission process for pharmaceutical, biotechnology, and medical device organizations. The platform provides an end-to-end automation solution for CDISC SDTM, ADaM, TFL, and Define-XML deliverables while maintaining full traceability, reproducibility, and regulatory compliance.
Designed specifically for the Life Sciences industry, TruForm transforms sponsor raw clinical data into submission-ready outputs through a secure, scalable, and audit-ready environment. The platform combines intelligent specification generation with deterministic, validated clinical programming workflows built on trusted Pharmaverse technologies including OAK, admiral, rtables, r2rtf, and ggplot2.
What Makes TruForm Different
Unlike generic automation tools, TruForm is built with a regulatory-first approach. AI is used only to assist with drafting mapping specifications from sponsor inputs such as protocols, annotated CRFs, raw data dictionaries, and CDISC standards. All downstream processing, dataset generation, derivations, and reporting are executed through validated and deterministic code workflows to ensure consistency, compliance, and audit defensibility.
This approach allows organizations to benefit from AI-assisted productivity while maintaining strict control over the regulatory-critical data transformation process.
Core Capabilities
TruMinds Clinical operates through a flexible US + Offshore delivery model that combines onshore client engagement and strategic oversight with scalable offshore execution capabilities. This approach enables:
- RAW to SDTM Transformation
Automated conversion of sponsor raw datasets into CDISC-compliant SDTM domains using metadata-driven workflows and validated transformation engines. - SDTM to ADaM Automation
Generation of analysis-ready ADaM datasets with reproducible derivations aligned with industry-standard ADaM implementation guidelines. - Automated TFL Generation
Creation of submission-ready Tables, Figures, and Listings (TFLs) using configurable templates and sponsor-defined shells. - Define-XML Generation
Automated metadata and Define-XML assembly with full traceability between source data, specifications, derivations, and outputs. - Audit-Ready Compliance Framework
Every run generates a complete audit package including generated code, logs, outputs, timestamps, version history, and immutable storage records designed to support regulatory inspections and sponsor QA requirements.
Key Features
- AI-assisted specification generation
- Deterministic and reproducible R-based workflows
- CDISC SDTM and ADaM compliant outputs
- Integrated validation and traceability
- Secure cloud-native AWS infrastructure
- Full audit trail and version control
- Project workspaces and role-based access
- Sponsor-owned and reviewable code generation
- Scalable enterprise deployment model
Built for Regulatory Confidence
TruForm is designed to support modern clinical development programs while meeting the high standards expected in regulated environments. The platform supports 21 CFR Part 11 readiness, GxP-aligned development processes, and complete traceability from source data to final submission deliverables.
By combining automation, transparency, compliance, and clinical domain expertise, TruForm helps sponsors and CROs reduce manual programming effort, accelerate study timelines, improve operational efficiency, and strengthen submission readiness.
The TruForm Principle
“Let AI draft the specification. Let validated code do the work.”
TruForm uses AI where it creates efficiency while ensuring that all regulatory-critical execution remains deterministic, reviewable, reproducible, and audit-ready.