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.
November 7th - 9th 2016
BIO-Europe is Europe's largest partnering conference serving the global biotechnology industry. Delegates from all parts of the biotechnology value chain come to BIO-Europe to quickly identify, engage and enter into strategic relationships that drive their businesses successfully forward. In addition to productive partnering, BIO-Europe offers high level workshops, panels, company presentations, and a lively exhibition.
Sacura will be present at the exhibition area this year. We are looking forward meeting you there.
If you want to meet SACURA at this event, please visit us at our stand, use the partneringONE® platform or contact us here.
MEDICA 2016 - World Forum for Medicine
November 14th - 17th 2016
The trade show MEDICA is the world forum for medicine with international trade fair and congress. About 5,000 national and international exhibitors present their latest devices, products and systems for outpatient and inpatient care at MEDICA.
If you want to meet SACURA at this event on Nov 15th or 16th, please contact us by e-mail.
November 25th 2016
Das 24. Symposium des Bundesverbandes medizinischer Auftragsinstitute e.V. (BVMA) widmet sich dem Thema "Risk-based Clinical Research: Schaffen wir das?". Das traditionelle Get-together findet am Vorabend statt.
Wenn Sie ein Treffen mit einem Vertreter von SACURA vereinbaren möchten, nutzen Sie bitte diesen Link.