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.
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.
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.
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.
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)
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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.
16th DIA Conference on European Electronic Document Management - Stop Paper Thinking!
May 23rd - 25th 2016
Leiden (The Netherlands)
The only conference focused on Electronic Content Management that brings together both regulatory agencies and industry to discuss the shift away from paper documentation. Sessions and speakers provide a life cycle approach to discussing all aspects of content management from documentation writing, through internal and external reviews and submissions, its use in line-of-business applications, and ultimately to archiving.
You will find here the DIA webpage. If you want to meet SACURA at this event, please contact us by e-mail or use the event's partnering.
XIV. BIONNALE 2016
May 25th 2016
BIONNALE is the largest networking event for life sciences and healthcare industries in the German capital region. For the first time ever, the BIONNALE 2016 will not focus only on biotechnology and pharmaceutical but also on medical technology.
You will find here the BIONNALE webpage. If you want to meet SACURA at this event, please contact us by e-mail, use the event's partnering or visit our booth.