RegDoc eSafe™

You have better things to do than learn a different binder system for every new study.

RegDoc eSafe: One place for all your binders, and for all your studies!


RegDoc eSafe is an electronic regulatory binder for investigator sites, providing a more convenient, efficient and precise tool to manage essential documents in clinical trials. Using the latest technology, RegDoc eSafe was designed with extensive input from study sites, and is built for intuitive use, rapid implementation and reliable performance. This is the first module on the Study eSafe™, a platform incorporating new digital solutions to empower investigator sites and streamline clinical trial operations.

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Fast and Efficient
  • Convenient work flows for regulatory coordinators
  • Document version control
  • Superior study closeout features
  • Rapid document retrieval
  • Improved ability to view status and manage completion of all documents

Wonderfully Flexible
  • Flexible design allows for folder customization
  • Organize the binders to match your site's work flow
  • Use your site's standard terminology

Secure and Auditable
  • Controlled, role-based access to documents and binder sections
  • Fully reportable audit trail of all document activities
  • Secure backup of binder documents to any location

Cost Effective
  • Eliminate the cost and space of paper archive storage
  • Reduce time spent scanning, faxing, printing and filing

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8 Great Features of RegDoc eSafe™

 
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1. Quick, Easy Controls

eSafe is designed to be fast, simple and intuitive. Clear controls make it easy to move documents, manage users, and complete tasks such as eSignatures and approvals.

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2. Familiar Binder Structure

eSafe is visually organized in sections and folders, similar to traditional regulatory binders, and it’s easy to set up e-binders with the same folder structure as paper binders.

 
 
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3. Role-based Access

Admins can assign every user a role, and align access to study binders and sections, as well as grant signing and approval authority, according to user role.

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4. Shared Documents Binder

Sites can create a binder of documents common to multiple studies, and as the documents are updated, new versions are automatically filed in applicable study binders, and replaced documents are archived.

 
 
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5. Binder Templates

Sites can create one or more templates of their preferred binder sections and sub-sections, and quickly start-up each new study binder by applying a selected template.

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6. eSignatures

eSafe makes it easy for Investigators or other authorized users to complete validated eSignatures on documents, including on-the-fly completion from mobile devices.

 
 
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7. Document Placeholders

Admins can create placeholders in a binder template or individual binder, and these serve as visual reminders that a specific document needs to be added to a specific folder

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8. Binder Export

At any time, sites can export study binders or individual documents from the eSafe cloud to a local drive, ensuring that you maintain possession of your binders.