myTI Integration Overview

TransPerfect’s Trial Interactive has supported customers for over 16 years across hundreds of clinical trials, securely managing critical trial documentation within a fully compliant Electronic Trial Master File (eTMF). It is a web-based, mobile-enabled SaaS platform delivering integrated eClinical solutions, including eTMF, CTMS, content management, Study Start-Up, and eLearning.

Trial Interactive’s myTI mobile application streamlines this process by providing secure, real-time access to study and site information via smartphone. CRAs, CROs, coordinators, and site personnel can scan and upload paper documents directly to the eTMF, update queried or expired documents, and access key contact information (e.g., central labs, CROs, contract facilities), reducing manual effort and improving operational efficiency.

The platform provides a globally compliant eTMF archive and CTMS that meet 21 CFR Part 11, Annex 11, ER/ES, GDPR, and GxP requirements, offering a single access point for all trial content and sponsor/site documentation. It supports complete TMF workflows - document import and indexing, quality review, audit readiness, certification, remote monitoring, and redaction - while enabling effective management of internally and externally generated documents through a validation-ready best-practice framework.

Trial Interactive features a thin-client, browser-based interface with iOS and Android mobile support, robust integration capabilities (API, ESB, SFTP, SSO), configurable document management for Clinical, Quality, and Regulatory functions, KPI dashboards and reporting, built-in machine learning for auto-classification and metadata extraction, and a GxP-compliant eLearning system. The solution supports the full clinical trial lifecycle from protocol conception through study closeout.

eTMF

Trial Interactive’s eTMF is a secure, cloud-based platform that enables real-time collaboration for sponsors and CROs while delivering enhanced transparency and inspection readiness. It supports AI-powered workflows for indexing and approval, automated document classification and metadata extraction, and alignment with the TMF Reference Model through required document lists and placeholders.

The solution strengthens compliance and oversight with KPI dashboards, timeliness tracking, query and task management, automated alerts, and quality review audit capabilities to ensure eTMF health, completeness, and inspection readiness. It captures secure email correspondence, supports document redaction and certification for data privacy, and includes built-in eSignatures compliant with 21 CFR Part 11 and ER/ES.

Additional capabilities include mobile content capture (iOS/Android), drag-and-drop imports, a universal document viewer (300+ formats), multi-document comparison and bulk editing, global cross-study search, configurable reporting and exports, completeness views, auto-routing and naming rules, and automatic duplicate detection—providing a comprehensive, validation-ready eTMF solution.

Collaborate

Trial Interactive Collaborate is an online, 21 CFR Part 11–compliant workspace that enables controlled document authoring, review, approval, and distribution across Clinical, Quality, and Regulatory functions. It provides shared collaboration rooms for study teams, CTMS users, and clinical sites—supporting document management, redaction, reconciliation, remote monitoring, and seamless transfer to the eTMF.

The platform enforces compliant document control workflows for policies, SOPs, and regulated content, with integrated training automation through the LMS. It supports real-time and offline co-authoring (MS Word®, Excel®, PowerPoint®), electronic and digital signatures, certified translation via TransPerfect TransPort, and secure collaboration with sites through mobile-enabled document collection and reconciliation. All processes align with required metadata, approvals, and signoffs before publishing to the TMF.

CTMS

Trial Interactive’s CTMS is a secure, cloud-based system that centralizes and manages all trial-related data in one location, providing a modern, mobile-first user experience. It enables study managers, CRAs, and clinical teams to plan, collaborate, and track studies with a single source of truth across products, programs, studies, countries, sites, subjects, and visits.

The system supports configurable, best-practice workflows aligned with SOPs, KPI dashboards for real-time oversight, inspection readiness controls, and structured planning of site visits, milestones, communications, and training. It integrates built-in content management and eTMF capabilities, customizable fields and validation rules, drill-down portfolio dashboards, and standardized reporting (standard and ad hoc).

Additional capabilities include a mobile visit report app (iOS/Android) with offline functionality, automated alerts and reminders, site and IRB correspondence tracking, EDC/payment/IXRS integrations, integrated LMS training, and role-based ownership controls. CTMS activities and visit status changes can trigger Events, required documents, and placeholders in the eTMF and collaboration workspaces, ensuring seamless alignment between trial execution and TMF archival.

GlobalLearn

Trial Interactive GlobalLearn is a compliance-focused Learning Management System (LMS) integrated with TI eTMF and collaboration solutions, creating a seamless flow from document authoring and approval to training delivery and archival. It enables sponsors, CROs, and sites to streamline study training logistics while maintaining regulatory compliance.

GlobalLearn provides a single access point for compliance assurance, consolidated training transcripts (including external training), visual dashboards for learners and managers, and group-based training assignments. It supports live, virtual, and blended learning with due dates, reminders, and progressive completion tracking.

The fully hosted solution is 21 CFR Part 11, ER/ES, and GxP compliant, with comprehensive audit trails, secure record protection and retrieval, role-based access controls, and course archival capabilities—helping organizations improve oversight, reduce risk, and lower training-related costs.