Collaborate Overview

This section explores the Collaborate Overview.

Trial Interactive provides an online collaborative workspace, which enables collaborative and controlled document authoring, review, and approval. Designed to include 21 CFR Part 11 compliant workflows and approvals, the solution offers an end-to-end service platform for your organization’s content management and document control requirements. The TI Collaborate rooms allow users to benefit from the following solutions:

  • Study Collaborate and the CTMS Collaboration Rooms are shared workspaces for clinical teams to manage and share documentation to be used in the clinical trial and ultimately shared with the eTMF.
  • Site Collaborate/eISF and Remote Monitoring Rooms are shared workspaces for sites to manage, redact, reconcile, and share documentation with the sponsor and CRO to conduct the clinical trial and ultimately send it to the eTMF.
  • The Quality Document Management solution provides controlled document workflows to an organization for use by clinicians, quality assurance, R&D, and other life sciences teams to collaboratively author, review, approve, sign off on, make effective, train, and distribute regulated content and documents.

TI Collaborate can provide your organization with:

  • A single place to share and collaborate on clinical documentation.
  • The ability to align document work streams with regulatory compliance practices for document authoring, approval, control, and related training.
  • The ability to enforce quality document control workflows on policies, SOPs, work instructions, and other critical documentation and to fully automate the training management process through the LMS.
  • The ability to co-author and collaborate with other authors in real time on new documentation both online and offline with MSWord®, Excel®, and PowerPoint®.
  • The ability to complete the end-to-end document process with an electronic and digital signature for document approvals.
  • The ability to send documents for certified translation through TransPerfect TransPort, track their status, and receive back the translated copies and certificates.
  • The ability to work with clinical sites in a remote monitoring and collaboration room, supporting mobile document collection, reconciliation, expected and planned documents, eSignatures, and collaborative authoring with the clinical site.
  • The ability to follow critical processes for metadata, approval, and signoffs by publishing or sharing directly with the TMF.