eTMF

Trial Interactive’s electronic Trial Master File (eTMF) is a secure, cloud-based solution enabling real-time collaboration for both sponsors and CROs, supplying value and ease of use for trial stakeholders across the board and now bringing enhanced transparency and visibility to the trial. Trial Interactive’s eTMF can help an organization in multiple ways including the following.

  • Ensure quality with the ability to have a customized workflow for indexing and approval powered by AI and machine learning.
  • Stay current with required document lists and placeholders based on the TMF Reference Model. Placeholders and required document lists ensure that all expected and essential documents are captured in your final TMF.
  • Track timeliness with KPI metrics dashboards that measure document intake from receipt to submission through QC and finalization.
  • Encourage better compliance with an eTMF that tracks responsibility and actively requests documents when they are due, supporting queries for document corrections through email or upload.
  • Confirm and maintain the validity of the eTMF before inspections using quality review audit capabilities to support oversight, periodic reviews, and inspection readiness.
  • Ensure overall reportable eTMF Heath with Key Performance Indicator (KPI) metrics, reports, and portfolio dashboards for eTMF health, timeliness, quality, and completeness.
  • Plan amendments, visits, and other key trial events and milestones while creating placeholders for the expected documents that need to be collected, including due dates and responsibility to help track eTMF health and timeliness.
  • Automate the classification and metadata extraction of the TMF using powerful AI auto-coding with human-aided machine learning.
  • eClinical platform interoperability provides a seamless connection and data flow between the eTMF and other critical applications such as a site portal, eISF and site binders, content management, document authoring, study startup, and clinical trial management systems.
  • Email and study correspondence inbox with relevance checks captures all email correspondence for each study. Once a correspondence email is sent in, it is rendered to PDF and may be selected for inclusion in a separate interface by study staff. Attachments are checked for duplicates and are linked back to the original email. Emailing documents and site correspondence securely into the eTMF ensures GCP compliance.
  • Document redaction, manipulation, and certification allow selected team members to remove personal information to meet data privacy requirements and repair, split, and merge documents. Additionally, document certification helps ensure proper paper disposal.

Additional features of the Trial Interactive eTMF include:

  • A mobile content capture app that supports both iOS and Android, with support for CRA reconciliation, metadata classification, query management, training, redaction, and offline mode.
  • Drag and drop emails and documents to import them automatically or drop them onto placeholders for auto-assignment.
  • Full query and task management capability with three types of queries for requesting, verifying, and responding via email, web, and mobile apps.
  • Automatic alerts and reminders with notifications and a daily digest.
  • Built-in eSignature and digital signature solution for 21 CFR Part 11 and ER/ES compliance with pre-defined signature blocks, pages, and digital certificate.
  • Universal document viewer that supports and renders over 300 document formats.
  • Multi-document view with built-in document comparisons, bulk editing, page rotation, deletion, reordering, and annotations.
  • Global search provides cross-study search results for documents, document types, full-text, contacts, sites, and other record types, with facets, filtering, and other advanced features.
  • Configurable grid filters, column selection, saved public/private views, and built-in reporting tools for ad-hoc exports.
  • Standard and ad-hoc reports that support all metadata fields and the ability to add columns to standard reports or fully customize your exports.
  • Completeness view showing TMF structure, final documents, planned documents/placeholders, and required documents.
  • Configurable support for the latest TMF reference model with full auto-routing and auto-naming rules.
  • Automatic duplicate document detection and comparison verifies that a document is unique and does not have a duplicate in the eTMF archive based on identical metadata or an exact copy or duplicate scan.