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etract abstract workflow
etract abstract workflow

What is e.tract?

e.tract is a web-based online platform for secure collaboration of all partners in clinical trials. 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. The system, which is developed by the companies Sacura and OrbiTeam Software is based on OrbiTeam's document management and collaboration platform BSCW.

  • 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

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

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Online Access to Your Study

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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

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

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The following services are inclusive: eTMF, collaboration areas, electronic signature, individual installation on server, customer's own sub-domain "yourdomain.e-tract.net", cloud hosting - solely hosted by a german hosting provider which is Data Star Audit and Trusted Cloud Service as well as ISO27001 certified.

All prices without VAT. One-off costs for Set-up: up to 50 users - 7,800 EUR, 51 to 100 users - 8,800 EUR, more than 100 users - 9,800 EUR. The eSignature module and a signature certificate is included in all installations. Please ask for attractive annual discounts. Individual cost calculations in the case of deviating conditions (e.g. user numbers, hosting, training etc.) are available on request.

UPCOMING EVENTS

BIO-Europe Spring®
March 20th - 22nd 2017

Meet us in Barcelona

Barcelona (Spain)
BIO-Europe Spring® is the premier springtime partnering conference which annually attracts an international "who's who" from biotech, pharma and finance for three days of high caliber networking. Featuring EBD Group's sophisticated partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative startups.
Sacura will be present at the exhibition area. We are looking forward meeting you there.

If you want to meet us at this event, please visit our booth or contact us here.

33rd Annual Meeting Pharmaceutical Medicine
March 23rd - 24th 2017

Berlin (Germany)
This year annual meeting of the German Society for Pharmaceutical Medicine (Deutsche Gesellschaft für Pharmazeutische Medizin - DGPharMed) is titled "Striking new paths?" Topics are: biomarkers, conflict and interests in CT, medical devices, CT and regulatory, and gene therapy.

If you want to meet us at this event, please contact us by e-mail.

German Biotechnology Days
April 5th 2017

Hannover (Germany)
The German Biotechnology Days are a meeting place for over 800 entrepreneurs, researchers and partners from politics, funding institutions and administrative. They are a forum to exchange experiences between all the actors of the German biotechnology scene.

If you want to meet us at this event, please contact us by e-mail.

XV. BIONNALE
May 17th 2017

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 800 participants in 2016. BIONNALE 2017 will again focus on biotechnology, pharmaceuticals and medical technology.

If you want to meet us at this event, please visit our booth or contact us by e-mail.

Contact Us

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