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etract abstract workflow
etract abstract workflow

e.tract eTMF

... an online platform for secure collaboration in clinical trials

e.tract is a web-based online platform for secure collaboration of all partners in clinical trials. The system is developed by the companies Sacura and OrbiTeam - the inventors of the first cloud computing system*). e.tract is based on OrbiTeam's document management and collaboration platform BSCW. The software simplifies editing, sharing, tracking and archiving of study documents. The central domains of this platform consist of individually structured workspaces and an electronic Trial Master File - eTMF.

  • Based on the current DIA TMF Reference Model and OASIS standards
  • Easy handling, minimal training requirements
  • Clear roles and responsibilities, improving the cooperation between involved partners
  • Increased transparency within working groups
  • Standardization of the collection, storage and management of TMF documents, consistent naming conventions
  • TMF structure provides clear descriptions and easy navigation
  • Simple features to search for documents via free text search, tags, document descriptions of the documents, indexes, etc.
  • 21 CFR part 11 compliant
  • Ensures completeness and quality of the TMF
  • Real time status
  • Continuous availability for mobile access with smartphones, tablet computers, etc.
  • Easy "one click" archiving of the eTMF

* The GMD (Fraunhofer FIT today) introduced the BSCW system in 1995 that would nowadays known as "the cloud". Documents could be web-based uploaded into folders and shared with others. Since 1996 BSCW is offered commercially by the Fraunhofer spin-off OrbiTeam.
See Wikipedia Cloud Computing - Geschichte (German language).

Core Features

Working-Groups

e.tract provides working groups for all partners in a clinical trial including a set of predefined roles and functions. e.tract enables the members of the working groups to act according to their tasks and responsibilities.

Close Collaboration

Each user in e.tract can create and manage documents in an individual workspace. Furthermore the shared workspace of the working group enables close collaboration and communication. e.tract enables cooperative creation and editing of documents. Direct access to all the trial documents the user needs is also included in the workspace (SOPs, Protocol, Monitoring Plan, Site-specific documents, etc.). Users can always react according to the business needs.

eTMF

The central eTMF of e.tract is based on the recommendations of the DIA, the current TMF Reference Model and OASIS standards. The eTMF provides a comprehensible filing structure for all documents to be archived in a clinical trial. The eTMF enables you to comply with the international standards for the handling of trial documents.

e.tract automatically generates an electronic site management section. In this area the members of each investigational Site and its supervising Monitor will find all site-specific and essential trial documents.

e.tract access

access1

Online Access to Your Study

access2

Request an Online Guest Account

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Guided Online Demonstration

Resources

Publications

Weltweit gemeinsam – Collaboration in Theorie und Praxis
Hartwig, G., Rescheleit, D., Koch, T.: Weltweit gemeinsam — Collaboration in Theorie und Praxis, Wirtschaftsinformatik & Management, February 2016, Volume 8, Issue 1, pp 58-61 Wirtschaftsinformatik & Management (Springer)
(Download PDF | Journal)

External Links to Further Information

NEW! EMA Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) (Link) will be legally effective on 18 Jun 2019

ICH GCP E6(R1) and its Integrated Addendum E6(R2): Section 8 - Essential Documents for the Conduct of a Clinical Trial, to be found at (Link)

Code of Federal Regulations Title 21 Part 11 "Electronic Records; Electronic Signatures" (Link)

Guidance for Industry "Part 11, Electronic Records, Electronic Signatures - Scope and Application" (Link)

Current version of the Trial Master File Reference Model (Link)

OASIS Electronic Trial Master File (eTMF) Standard Technical Committee (Link)

Digitale Archivierung papierbasierter Krankenakten von Studienpatienten – Eckpunktepapier des KKSN, der GMDS und der TMF unter Mitwirkung des BfArM und der Landesüberwachungsbehörde Nordrhein-Westfalen (Link)

Pricing

Please ask for an individual proposal. The pricing is based on the following different models that can be adapted to your needs:

  • Site based model
  • Associations and academic institutions
  • IIT (investigator initiated trials)
  • Read-only access

UPCOMING EVENTS

2019 German Biotech Days (D.B.T.)
April 9th - 10th, 2019

Würzburg (Germany)
The DBT are a meeting place for more than 850 representatives from the worlds of business, science and government, including partners from funding institutions and public administration. It is Germany's leading biotech event.

If you want to meet us at this event, please contact us here.

8th BIONNALE 2019
May 7th, 2019

Berlin (Germany)
BIONNALE is the largest networking event for life sciences and healthcare industries in the German capital region. Representatives from academia and industry attend the annual event to identify, engage and enter into strategic partnerships. The networking character is one strength of the multi-sessional, international event which was attended by more than 900 attendees in the last year.
The Biotech/Pharma Session at BIONNALE 2019 will be held in cooperation with CONELIS. Winning with external expertise - real-life examples from the industry’s value chain presented by members of the CONELIS network. CONELIS – the Competence Network Life Sciences – is an association of selected, independent experts providing top-tier consulting services to the life sciences industry. SACURA is supporting member of CONELIS.

If you want to meet us at this event, please contact us here.

Contact Us

Got questions about e.tract? Drop us a line!