Introduction

TransPerfect’s Trial Interactive has been used successfully by TransPerfect customers for over 15 years in hundreds of clinical trials to store critical trial documents as part of the Electronic Trial Master File. Trial Interactive’s platform is a web-based and mobile-enabled software-as-a-service (SaaS) application that provides eClinical solutions for eTMF and content management, Study Start-Up, and various other tools used in conducting a clinical trial. Trial Interactive’s products deliver a wide range of benefits to any organization looking to leverage new efficiencies and opportunities in their Trial Master File, clinical trial management, content management, and eLearning:

  • An electronic Trial Master File archive that meets all regulatory, security, access, and storage requirements in all countries and regions.
  • A Clinical Trial Management System (CTMS) that meets all eClinical requirements for managing and tracking clinical studies and works seamlessly with the eTMF, Content Management, Learning Management, Mobile app, and other Trial Interactive solutions.
  • A fully hosted SaaS solution that is 21 CFR Part 11, Annex 11, ER/ES, GDPR, and GxP compliant.
  • A single access point for all trial content as well as sponsor and site personnel documentation.
  • Supports a series of TMF workflows, including document import and indexing, quality review, audit and inspection, document certification, remote monitoring, redaction, and the capture of other Clinical Trial documentation.
  • Effective management of documents that are created internally or externally. Trial Interactive is the only solution that provides a best practice and validation-ready approach to creating, collecting, reviewing, and finalizing documents bound for the eTMF archive.
  • A thin-client, consumer-grade user interface that supports most major browsers and a mobile app that supports iOS and Android devices.
  • A powerful, flexible technical stack with many integration options, including an API, Event Service Bus, SFTP Dropbox, and Corporate Directory Integration with Single Sign On.
  • Increases teamwork and collaboration via one global view of clinical trials, training, and supporting documentation.
  • A flexible, configurable document management solution for Clinical, Quality, and Regulatory documentation that supports a series of reviews and authoring solutions.
  • Dashboards and reports that provide KPIs, measurable metrics, simple Excel exports, as well as complex standardized and custom reports.
  • Adaptable, built-in machine learning features such as auto-classification and metadata extraction enable AI auto-coding capabilities.
  • A full-featured eLearning system designed for GxP compliance, study training, and virtual investigator meetings.
  • Effectively manage the entire clinical trial process from protocol conception through closeout.