Platform
Planned

Manage Essential Records Across the Study Lifecycle

eReg / eISF

The planned regulatory module will give sites a structured workspace for essential study records, staff qualifications, document review, and ongoing maintenance. Regulatory teams can identify gaps and coordinate corrective work across studies and locations.

Illustrative platform view
Regulatory Binder

Binder Completeness

91%

across 4 studies

Pending Review

7

documents

Expiring (90d)

5

credentials

Open Findings

3

corrective tasks

Documents by State

AURORA-1 — Protocol v3.0

Approved

Current

NEPTUNE-3 — ICF v2.1

Pending review

Review

HELIOS-2 — PI CV

Expires in 30 days

Expiring

ORION-4 — GCP Certificate

Superseded

Archived

Illustrative concept using fictional data. Capability availability is planned.

Planned capabilities

What this module is designed to do

Capabilities are grouped by operational purpose. Each is described as planned until availability is confirmed.

Configurable Electronic Binders

Organize records by study, location, investigator, and document category. Support approved filing structures and document metadata.

Document Lifecycle Management

Track draft, review, approved, superseded, expired, and archived states. Maintain version history and identify the current approved record.

Qualifications and Training

Manage CVs, professional licenses, GCP certificates, study training, and assigned responsibilities. Highlight expiration dates and missing evidence.

Study and Amendment Tracking

Organize applicable approvals, protocol versions, consent document versions, and related correspondence. Assign follow-up for records affected by amendments.

Readiness and Quality Review

Assess binder completeness against configured requirements. Record review findings, assign corrective tasks, and follow unresolved items.

External Review and Closeout

Provide controlled reviewer access and organize closeout activities, record exports, and archiving requirements.

Workflow example

How it comes together

A protocol amendment prompts a document review. Regulatory staff identify affected records, assign updates, and confirm that the required documentation has been filed.

  1. 1

    A protocol amendment is logged with the new protocol and consent versions.

  2. 2

    Regulatory staff identify affected records across studies and locations.

  3. 3

    Corrective tasks are assigned to owners with deadlines for updates.

  4. 4

    Updated records are filed and version history is maintained.

  5. 5

    Binder completeness is assessed against configured requirements.

Role-based views

Relevant views for each role

The same connected records surface differently for each role, so people see what matters to their responsibilities.

Regulatory Coordinator

Binder completeness, document states, and corrective tasks.

Quality Manager

Review findings, unresolved items, and expiration monitoring.

Principal Investigator

Assigned qualifications, training records, and pending follow-up.

Connected modules

Works with the rest of the platform

This module connects with the others so study, document, and financial workflows stay in sync.

AI assistance

AI-assisted support in this module

AI helps staff review information, prepare drafts, and organize work. Staff review every output and retain control of decisions.

Document search across regulatory records

Expiring credential and training reminders

Summary of outstanding regulatory review tasks

AI-generated content requires staff review. The platform must identify uncertain or missing information and must not autonomously determine eligibility, diagnose conditions, or make treatment decisions.

Frequently asked questions

Discuss Your Site's Needs

Let's talk about your site or network

Evoright 360 is in development. Tell us about your workflows and priorities, and our team will walk through how the platform can come together for your site or network.

Evoright 360 does not collect patient information through this form.