21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
AIGenerative AI for biostatistics and clinical data (Module in Training stage)
A generative AI platform specialised for clinical data work.
Galax Gen AI is a generative AI platform built for biostatistics and clinical data teams. It supports statistical analysis plans, data review, SDTM and ADaM, TLFs and programming in SAS, R, Python and GLX, and extracts data from PDFs into Excel. Users work in a chat interface; administrators control access and configuration in a separate panel.
- 4
- Languages: SAS, R, Python and GLX
- 2
- Panels: user and admin
- PDF→Excel
- Data extraction
Capabilities
A generative AI platform specialised for clinical data work.
6 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Statistical analysis plans
Help drafting and reviewing SAP content.
- SAP section drafting support
- Review of analysis methods and populations
- 02
Data review
Assistance with clinical data review tasks.
- Questions answered against study data
- Support for listing and consistency review
- 03
CDISC & TLFs
Support across SDTM, ADaM and outputs.
- SDTM and ADaM mapping and derivation help
- TLF programming support
- 04
Programming help
Write, explain and fix statistical programs.
- SAS, R, Python and GLX
- Code explanation and correction
- 05
PDF-to-Excel extraction
Turn document tables into structured data.
- Extract tabular content from PDFs
- Export to Excel for review
- 06
Chat, user and admin panels
A familiar chat interface with controlled administration.
- Chat interface for everyday questions
- User panel for personal work
- Admin panel for users and configuration
How it works
One accountable path from set-up to evidence.
Galax Gen AI runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Ask
Describe the task in the chat.
- 02
Draft
Galax Gen AI drafts code, text or extracted data.
- 03
Review
The specialist reviews and corrects the result.
- 04
Use
Take the reviewed output into the controlled workflow.
Quality and control
Designed for regulated clinical work.
Platform controls and documented procedures support the sponsor's validated, risk-based use.
Role-based access
Each role sees only the screens and actions it is permitted, per environment.
Tamper-evident audit trail
Every change is attributable, time-stamped and kept with before and after values.
Validated deployment
Released under documented IQ/OQ/PQ, on-premise or in your cloud.
Who uses it
- Biostatistician
- Statistical programmer
- Data manager
- Medical writer
Contact
See Galax Gen AI on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.