Electronic Trial Master File

Automated Clinical Trial Content Management

Designed by and for Clinical Operations professionals, SureETMF™ is a cloud-based regulatory content management application for electronic trial master file ( ETMF ) documents and DICOM medical image management. With FDA Part 11 compliance validation, SureETMF automates the capture, digital completion, signing, classification and tagging of content via collaborative portals. Designed to be easily used from any device, clinical trial stakeholders can collaboratively view, share, digitally esign, comment on and manage content from mobile, web or desktop.

Simplify and streamline clinical trial content management tasks with SureClinical’s unified suite of cloud applications. SureClinical – the fastest path to success.

Rapid Implementation

Study Creation Wizard

Our study creation wizard helps you start your study in minutes, not months. Setup and configure the system quickly without expensive consulting or setup fees.

Support Any Reference Model

Configurable Templates

Tired of paying your ETMF vendor to customize your ETMF model? SureDesigner lets you quickly modify your electronic trial master file plan to meet your needs. Add standards-based tags to facilitate automated classification, search and reporting. When you are done, save your filing plan as a reusable template. Most importantly, you can make these changes on your schedule, efficiently and at no cost.

Digital Content Capture

Eliminate Manual Processes

Say goodbye to manual content capture processes such as wet signing, printing, scanning, uploading, tagging, naming, and classifying. Say hello to best in class Adobe digital certificate signing, automated PDF form and document completion workflows with collaborative portals, real-time content capture with automated tagging, proactive content completion notifications, analytic dashboards and more to save you time and enhance quality.

Multi Channel Content Capture

Capture, Classify, Complete, Sign

Automate the capture, classification, completion and signing of documents and medical images via workflows, web portals, email, web PDF forms and surveys with real-time updates to document milestone gadgets and reports. Bring in content from any source, even Outlook drag-and-drop via our multi-channel content capture platform.

Dashboard Analytics

Understand what you have and what you need

Dynamically track required, missing, expired documents and content, milestones and workflows. Forecast milestone completion to ensure successful on-time project completion.

Predictive Analytics

Understand where you are going

Get a 360-degree view of important project milestones and data. Mitigate risk and forecast your ability to complete essential document collection, workflows and milestones on-time.

Enterprise Collaboration

Connecting People, Processes & Content

Easily manage, share, and track documents through our collaborative team network. Digital document signing, web PDF form and web survey completion via review and approve workflows reduce completion times, enhance data quality and reporting.

Collaborative Clinical Network

Share Content, Knowledge & Insight Globally

Unlike legacy systems that lock your operations behind a firewall, SureETMF is the only ETMF that provides a global trusted clinical network for central management of essential documents. With SureETMF and SureNetwork, you have the ability to import centrally managed documents from SureNetwork’s Person or Org profiles into your ETMF. Get automated updates for the latest licenses, CVs, financial disclosures and more with one click on a person’s profile. (requires SureNetwork)

SureDesigner

Data Model Design Wizard

SureDesigner provides an easy to use editor tool that lets you view and edit the content classification structures that reside within the SureClinical platform. Using a drag and drop graphical user interface, you can examine content types, metadata and relationships in an existing content model.

Whether you want to start with your own organization specific content model (filing plan) or you want to use an existing TMF template, with SureDesigner you can quickly configure your content model with flexible form fields, folder structures, and more. When you complete your model, you can save it as a reusable, interoperable template that can be shared with others. SureDesigner™ is a revolution in ETMF content management, using next generation semantic web standards that have been widely adopted in bioinformatics for seamless content model and information sharing

SureClinical

The Fastest Path to Success

Customers and Users

"Our users, sponsors, and investigators are delighted by SureClinical’s suite of eClinical applications, including SureCTMS, SureETMF, and SureDrive."

Gary ZammitCEO of Clinilabs Drug Development Corporation

"Of all of the systems I use, SureClinical is the best Clinical Trial Management Software."

Deana DowdCRA Consultant, First Coast Clinical Research

“With SureClinical, we cut our clinical trial project startup time in half. Going digital was not only a significant time saver, but it also enhanced the quality of our data.”

Global CRO

"With SureClinical eTMF Cloud, internal and external study stakeholders can collaboratively complete, digitally sign and share regulatory and study information in the cloud from mobile or web. This strategic capability allows us to eliminate paper at point of origin, accelerating document completion and enhancing document quality."

Lynda ShelleyExecutive Director of Clinical Operations, Novotech

”With SureClinical, our goals of going digital have been met. We tested and sandboxed many systems before making the decision to go with SureClinical for SureETMF and SureCTMS. Our own client users are passionate about the software and it is incredibly easy to initiate, file and manage documents and trials."