What is an eISF and why does it matter?
An electronic Investigator Site File (eISF) replaces traditional paper binders with a secure digital system to manage regulatory and study-related documents. It helps sites stay organized, reduce errors, and be audit-ready at all times.
Can we use our existing documents and folders in SiteCentric?
Yes! You can upload files or forward them via email, then easily organize them with drag and drop; you can even use your existing naming conventions. SiteCentric also supports structured study binders and master file templates to simplify setup.
Is the SiteCentric eISF Part 11 compliant?
Absolutely. SiteCentric meets all 21 CFR Part 11 requirements, including secure access controls, eSignatures, audit trails, and version tracking. Each document is also protected with a blockchain-based digital fingerprint to ensure its integrity.
How does remote monitoring work in SiteCentric?
CRAs and auditors are given secure, permission-based access to view eISF documents remotely. They can see what’s changed since their last review and download approved files—without needing additional logins or manual uploads from your team.
What happens when a document expires?
SiteCentric automatically notifies the appropriate staff when documents—like CVs, training logs, or licenses—are nearing expiration. When an updated document is uploaded, it is automatically synced across all linked study binders.
Can we track training and credentialing inside the eISF?
Yes. Staff training records are securely stored and linked to the appropriate study binders. You can generate reports by study, staff member, or training topic to demonstrate compliance during audits.
