SureClinical eTMF automates document and medical image acquisition, classification and retention for BioPharma Clinical Trials

Automate Your Work

Eliminate manual paper handling tasks by automating the acquisition, classification, indexing and archiving of docs, email and medical images.

Ensure Quality

Ensure document quality, track regulatory document compliance and lower auditing costs.

Flexible Platform

Supports standards-based technologies to facilitate interoperability with existing systems. Open architecture.

Sign Anywhere

Save time and money and enhance quality by acquiring documents at the point of creation. Capture regulatory agency compliant digital signatures.

Work Anywhere

Freedom for your clinical trial workforce with support for Windows® PCs and Apple® Mac OS. Securely access records online or offline.

Secure Sharing

Share content securely online or offline using US FDA, EMEA and HIPAA compliant FIPS-140 encryption standards.

SureClinical – Collaborative Cloud for Clinical Trials

SureClinical offers collaborative cloud application solutions that automate manual content management processes in health sciences. Built on an FDA Part 11 and HIPAA certified cloud platform with integrated high-trust digital signing, BioPharma companies can eliminate paper and accelerate the delivery of new therapies to market with significant cost and time savings.

SureClinical eTMF is a regulatory document solution which enables BioPharma clinical trial stakeholders to securely acquire, view, share and manage clinical trial electronic content for electronic trial master files. SureClinical eTMF maximizes productivity and document quality for clinical trials by automating manual paper-handling processes such as document signing, classification, indexing, archiving and other labor intensive clinical trial content management processes. SureClinical eTMF ensures that study documents, medical images and eRecords for BioPharma clinical trials are always available to all stakeholders, either online or offline. Using industry standard technologies, SureClinical eTMF lets you create an interoperable eTMF model with published templates, or ‘content classification models.’ SureClinical eTMF lets you use any eTMF content model, or you can modify and edit provided content model templates to meet your needs. SureClinical eTMF is used by clinical trial Sponsors, Investigators, Clinical Research Associates and others who wish to install automated, secure, and cost-effective eRecord handling in clinical trials.

Benefits

  • Save time and complete trials in less time
  • Lower clinical trial costs
  • Enhance clinical trial document quality and integrity
  • Deploy eTMF on new studies in days not months with SureClinical Secure Cloud

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Eliminate paper at the point of creation – deploy SureClinical eTMF cloud for clinical trials.

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Features

  • Integrated suite of applications for quality, compliance, medical imaging and more using an open, standards-based platform that integrates with most popular content management solutions
  • Automate manual paper handling processes for higher electronic document and eRecord quality
  • SureClinical’s Triple-View™ provides users a view of the document hierarchy, metadata and document viewing in a single view
  • Advanced search and reporting capabilities with custom reports by site, by person, by study subject and custom reports
  • Create collections of content and share it securely with internal or external team members using secure content sharing technology
  • SureDesigner content model tool enables rapid customization to maximize flexibility and interoperability
  • Flexible set of predefined views for clinical trials or create your own custom views with the view wizard
  • Web downloadable desktop clients for Windows PCs or Apple Mac OS
  • Support for both online or offline operation

Products

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