eTMF with CARA
including Site and Investigator Portals

DIA EDM Reference Model

DIA EDM Reference Model

Document and metadata set – starting from the reference model

Template-based Approach

Template-based Approach

Create documents, full eTMF structure and add sites, all from templates – all fully configurable

Portal / Cloud

Portal / Cloud

Simple and secure access for read only. Cloud-enabled for both internal and external users

CTMS and other Integrations

CTMS and other Integrations

Integrate with multiple systems within the CARA UI and push / pull data or documents to/from submissions, CTMS etc.


CARA for electronic Trial Master Files is a configuration package of the standard CARA product to provide functionality required for managing all Clinical Trial Master File documentation and related information. This package is based on the EDM Reference Model. The CARA Portal for Investigators and Clinical Trial Sites to upload data to your repository. Additionally, the CARA Hub functionality allows you to display and update information from third party systems (e.g. CTMS, submission management, master data management) using web services, JSP or other easy integration points.


  • Based on the EDM Reference Model for metadata model
  • eTMF template structures included
  • Ability to create contexts so that documents included in multiple studies can have different metadata (e.g. Investigator CVs)
  • De-duplication of data – manage and report on duplicate files
  • Wizard for creation of content based on templates
  • Integration with simultaneous authoring / review tools e.g. from PleaseReview, i4i and Brava
  • Full cycle of creation, authoring, review and approval including eSignature
  • Easy drag-and-drop to create and manage Trial Master Files
  • Use metadata and CARA dashboards to manage TMF information
  • Ability to have external CROs and Investigators or Trial Sites contribute documents directly into your docbase via the CARA Portal – uploading to a staging area where files can then be fully tagged
  • Study Tagging information for the CTD
  • Ability to tie TMF documents into submissions (see separate CARA Regulatory Affairs package)
  • Fully multi-lingual including many European languages as well as Japanese, Chinese, and Russian.


CARA benefits

Maximise the user experience
simple to learn and use and personalised to each individual’s requirements

Access and manage content from one place
a single destination user interface, integrated seamlessly with multiple systems

Meet corporate and regulatory standards
configure CARA to suit your exact requirements

Supports the full document lifecycle
from creation to access, search, review, approval and publication

Automate manual processes
with CARA workflows

Easily navigate and search content
CARA provides multiple ways to access the information you need

Securely access content on the go
our mobile apps give you the full CARA experience

Securely share information with external partners
secure third-party access, watermarking and more

Over 500,000 users and growing…