UD Clinical Trial Master File

Enterprise · Free during beta

Create ICH E6(R3) GCP compliant Trial Master Files as tamper-evident governed .udz archives. Documents organised by DIA TMF Reference Model sections, with cryptographic provenance record on every file.

✦ Enterprise · Free during beta — Veeva Vault charges $50,000–200,000/year

Trial title *

Protocol number *

Sponsor name *

Principal Investigator

Trial phase

Therapeutic area

IND/CTA number

Trial close date (for expiry)

TMF documents

Drop TMF documents (multiple files) · or click to browse

ICH GCP compliance by construction

ICH E6(R3)

Every document carries ICH E6(R3) compliance metadata. The standard is embedded in the provenance.

DIA TMF Reference Model

7 standard sections per the DIA Reference Model. Documents auto-tagged to the correct section.

Cryptographic provenance record

Every document has a cryptographic timestamp proving it existed before inspection.

GCP classification

Essential vs non-essential documents flagged at upload — supports inspection readiness.

UD Clinical TMF vs Veeva Vault

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Veeva Vault

$50,000–200,000/year. 6–12 month implementation. Requires dedicated validation team. CSV required.

🏛

Phlexglobal

Similar enterprise pricing. Traditional eTMF approach. Long-term vendor lock-in.

📂

Manual TMF

GCP non-compliance risk. Inspection failure risk. Cannot prove document existed before inspection.

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UD Clinical TMF

Enterprise Scale tier. ICH GCP compliant by construction. Cryptographic provenance record on every document. Inspection-ready.

Processed in your browser. No files stored on our servers. Part of the Universal Document™ ecosystem.