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eISF & eTMF Workflows
Connect Sites & Sponsors Seamlessly
Purpose-built digital workflows for compliance, collaboration, and control.
In clinical research, scattered document systems and mismatched workflows lead to delays, errors, and compliance risk. SiteDocs Portal™ bridges the gap with a unified eISF and eTMF solution — connecting Sites, CROs, and Sponsors in real-time. Whether you’re managing Investigator files, maintaining Electronic Site Signature and Delegation Logs, or archiving for inspection, everything stays aligned, accessible, and audit-ready.
eISF & eTMF Sync
One source of truth – Keep Sponsor and Site documentation aligned from day one. SiteDocs Portal™ ensures seamless file handoffs, version parity, and linked workflows, reducing duplication, confusion, and rework.
Electronic Signature & Delegation Logs
Built-in compliance from day one.
Capture, track, and manage Electronic Signatures alongside Site Delegation of Authority Logs — all within your eISF. Ensure every signature and role assignment is secure, traceable, and inspection-ready.
Real-Time Oversight
Always audit-ready – Give Sponsors and CROs secure access to what they need, when they need it. No more chasing files, emailing ZIPs, or manually reconciling versions — just real-time visibility.
Automated Filing Workflows
Built for Sponsor expectations
Automate the filing process with pre-set workflows and naming conventions that meet eTMF requirements. Keep documents moving from upload to archive
— without missing a step.
Inspection-Ready Archive
Nothing lost. Everything locked.
Documents are securely stored, time-stamped, version-locked, and ready for inspection at any time — without scrambling at closeout.
Audit-Ready from Day One
Remove the stress of inspections with built-in compliance, clarity, and control.
Managing essential documents across Sites, Sponsors, and CROs doesn’t have to be a nightmare. SiteDocs Portal™ delivers a unified solution that aligns your eISF and eTMF workflows, keeps everything version-locked and time-stamped, and ensures every stakeholder has access to what they need — without the back-and-forth.
From onboarding to archiving, our team helps you configure, file, and stay inspection-ready without the guesswork.
Purpose-Built for Clinical Documentation
SiteDocs Portal™ aligns your document workflows from the moment you log in — so you’re not just storing files, you’re ensuring every signature, milestone, and version is compliant, trackable, and accessible when it matters most.
Whether you’re transitioning from paper, upgrading outdated systems, or managing multinational submissions, SiteDocs Portal™ meets you where you are. Our modular tools adapt to your existing structure, while our onboarding team works alongside you to configure, train, and launch with minimal disruption. From single-site Phase I studies to global Phase III rollouts, we help you digitise with confidence — and stay inspection-ready every step of the way.
Effortless Document Sync Across
Sites, Sponsors & Systems
No More Folder Chasing
Tired of scattered folders, email attachments, and documents? With SiteDocs Portal™, every document lives in one secure, compliant location — version-locked, time-stamped, and ready when you need it. Whether you’re managing a study or reviewing Sponsor feedback, you’ll always know where the latest file is.
Instant Sponsor Access
SiteDocs Portal™ makes Sponsor access seamless — giving external Stakeholders live visibility into the documents they need, without exposing what they don’t. Say goodbye to endless zip files and uploads. Grant instant access by role or study and maintain complete control over what’s shared.
Built for Oversight.
Trusted for Compliance.
eISF and eTMF shouldn’t be siloed, mismatched, or out of sync. With SiteDocs Portal™, Sponsors, Sites, and CROs collaborate in real time through integrated, compliant workflows that align from first file to final archive. Whether you’re migrating from paper, digitising a portfolio, or coordinating across geographies — SiteDocs Portal™ brings everything together, without adding complexity.
Unified Document Ecosystem
One platform. Zero duplication.
SiteDocs Portal™ eliminates the disconnect between eISF and eTMF by giving Sponsors, CROs, and Site teams access to the same live, compliant files — with role-based permissions to keep everything in check. Say goodbye to email attachments, mismatched folders, and end-of-study scrambles.
Real-Time Filing & Reconciliation
Always up to date. Always inspection-ready.
SiteDocs Portal™ automates document indexing and reconciliation in real time — so nothing is left behind or misfiled. Upload once, file instantly to your Sponsor’s eTMF or SIP with mapped folders and audit trails that meet regulatory requirements. No backlog, no panic before close-out.
Custom Folder Structures
Your protocol, your way.
With SiteDocs Portal™, you’re not locked into a one-size-fits-all system. Design folder structures that match your CTA, Study protocol, or Sponsor template — and replicate them across Sites with ease. Built-in flexibility means full compliance without complexity.
Sponsor-Ready from Day One
Align your workflows before the first file is signed.
SiteDocs Portal™ is interoperable with major Sponsor systems — including SIP and eTMF integrations — and structured to meet compliance standards from day one. No rework. No last-minute reshuffling. Just smooth, aligned document management your Sponsor will thank you for.
Security & Compliance from the First Upload
From Investigator folders to final Sponsor archives, SiteDocs Portal™ builds compliance into every step. With role-based access, real-time audit trails, and secure AWS hosting, your eISF and eTMF are protected, aligned, and always inspection-ready — without the need for add-ons or manual tracking.
CFR Part 11 & ICH GCP R3 Aligned
Electronic signatures, locked version histories, and time-stamped audit trails ensure that every step meets regulatory standards. SiteDocs Portal™ gives you confidence that your documentation is ready for any Sponsor audit or Regulatory review.
Granular Role-Based Access
Not everyone needs to see everything. Assign specific access by Site, Sponsor, Monitor, or Team role — and ensure the right documents are always visible, editable, or restricted based on your workflow needs.
Secure Cloud Infrastructure
Hosted on local, in-region AWS servers with end-to-end encryption and daily backups, SiteDocs Portal™ keeps your Clinical data protected, private, and fully recoverable. No compromises, no third-party patchwork — just built-in security from day one.