e.tract

e.tract eTMF, developed by Sacura GmbH, is an online platform designed to facilitate secure collaboration in clinical trials. With a focus on the Trial Master File (TMF), e.tract simplifies the editing, sharing, tracking, and archiving of study documents. This solution is suitable for a wide range of professionals and industries, including Clinical Research Organizations (CROs), pharmaceutical companies, contract research organizations (CROs), academic institutions, and investigator-initiated trials (IITs).

Key Features

Collaboration: According to the vendor, e.tract provides a collaborative environment for all partners involved in a clinical trial, allowing for close collaboration and effective communication. Users can create and manage documents in their individual workspaces, while the shared workspace enables cooperative document creation and editing.

eTMF: According to the vendor, the central eTMF of e.tract follows the recommendations of the DIA, the current TMF Reference Model, and OASIS standards. It offers a comprehensive filing structure for all trial documents, ensuring compliance with international standards. Additionally, it automatically generates an electronic site management section containing site-specific trial documents for each investigational site.

Easy Handling: The vendor claims that e.tract is designed for easy handling and requires minimal training. The platform offers clear roles and responsibilities, enhancing cooperation between partners. It aims to promote transparency within working groups, facilitating smoother collaboration.

Standardization: According to the vendor, e.tract promotes the standardization of collecting, storing, and managing TMF documents through consistent naming conventions. The TMF structure provides clear descriptions and easy navigation, improving organization and accessibility. It also offers simple search features, including free text search, tags, document descriptions, and indexes.

Compliance: The vendor states that e.tract ensures regulatory compliance by being 21 CFR part 11 compliant. It aims to maintain data integrity and traceability, guaranteeing the completeness and quality of the TMF. Real-time status updates are provided to offer visibility into trial progress and document management.

Mobile Access: The vendor claims that e.tract offers continuous availability for mobile access, allowing users to access trial documents on the go using smartphones, tablets, and other devices. It also aims to simplify the document archiving process with one-click archiving of the eTMF.