... 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.
* 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).
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)
EMA Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (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)
Please ask for an individual proposal. The pricing is based on the following different models that can be adapted to your needs:
European Trial Master File
September 25th - 28th, 2017
Case-study led TMF and inspection readiness conference. This conference will arm you with the insight you need to perfect your TMF, and achieve constant inspection readiness. If you want to find out exactly what the regulators expect, as well as what others are doing.
If you want to meet us at this event, please contact us here.
November 6th - 8th, 2017
The 23rd annual 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. Investment and collaboration opportunities developed in prior BIO-Europe® conferences have produced many highly successful business partnerships.
We 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 #102 or contact us here.
November 24th, 2017
Das 25. Symposium des Bundesverbandes medizinischer Auftragsinstitute e.V. (BVMA) widmet sich dem Thema "Klinische Forschung im europäischen Wandel: Patients first!".
Wenn Sie im Vorfeld ein Meeting mit uns vereinbaren möchten, klicken Sie bitte hier.