ELECTRONIC TMF & ISF — Unified, Compliant, and Built for Real Clinical Operations

One Platform. Two Perspectives. Zero Duplication.

EasyTMF® and EasyISF© form an integrated, cloud-ready document management environment designed for modern clinical trials.
Sponsors, CROs, and investigators work within one validated system while keeping strict separation of responsibilities, permissions, and data visibility.

✔ Full TMF oversight for Sponsors & CROs
✔ Site-specific ISF access for Investigators
✔ No document duplication
✔ Full audit trail and GCP alignment
✔ Faster startup, inspection-ready from Day One

Download: EasyClin®
Unified Platform Strategy

1 \ One Platform – Two Interfaces

EasyTMF® and EasyISF© run on a unified, validated architecture:

Sponsor/CRO view (TMF): full trial oversight, DIA Reference Model aligned
Site view (ISF): investigator-focused, site-specific access only

2 \ EasyTMF® – Trial Master File

Central TMF dashboard and DIA RM structure
Full audit trail, e-signatures, remote inspection
Validated under ISO 13485 / 14971 / 27001 / IEC 62304 / GAMP5

3 \ EasyISF© – Investigator Site File

Central TMF dashboard and DIA RM structure
Full audit trail, e-signatures, remote inspection
Validated under ISO 13485 / 14971 / 27001 / IEC 62304 / GAMP5

4 \ Integrated Advantages

No document duplication, one audit trail
Faster onboarding, fewer systems to validate
Flexible deployment: one ISF per trial or one ISF per hospital hub

5 \ Regulatory Acceptance

Electronic TMF/ISF on external cloud platforms is accepted by regulators (ICH-GCP E6(R2), 21 CFR Part 11, EMA eTMF guidance, GDPR, HIPAA, NHS DTAC) when the system is validated, access-controlled, and audit-ready.
EasyTMF® and EasyISF© meet these expectations via GDPR-native hosting (e.g. AWS Frankfurt, StackIT, PCG) and HIPAA-compatible setups for US clients.