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Reducing Risk for Regulatory Professionals

Approvals hinge on submissions. Speed submissions and regulatory approvals with practical support for document work streams like study start-up, training, and quality documents. Our 21 CFR part 11-compliant platform helps organizations maintain precise documentation, timely compliance, and real-time knowledge of regulatory updates.
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Achieve Global Regulatory Compliance

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Global Support for Regulatory Documents and Submissions

Trial Interactive helps regulatory professionals prepare and submit their regulatory documentation and get to approval faster.  Author, review, approve, and manage document submissions in a single 21 CFR Part-11-compliant platform.

Enable Cross-Functional Collaboration and Real-Time Audit Preparedness

  • Part of the Trial Interactive Life Sciences Platform

  • Configured Issue/CAPA Workflows

  • Document Management and Authoring

  • Easily Initiate Related Workflows

  • Mobile App with Approval Support

  • Calendar View with Audit Scheduling

  • Active Alerts and Notifications

  • Email Correspondence and Bulk Upload

  • Quality Workflow Wizard

  • Fast and Flexible QMS Implementation

  • Configured Audit Management Workflows

  • Integrated Training Management and eLearning

  • Corporate Directory Integration with Single Sign-On

  • Quality Dashboard and Standard Reports

  • 21 CFR Part 11, GxP, and GDPR Compliant

  • 24x7 Help Desk Email and Phone

  • TI Digital Sign w/ Signature Block and Manifestation

  • Comprehensive Validation Package

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From site identification to close-out, clinical document processes and operational oversight are complex. Our electronic trial solutions simplify your clinical operations: expedite timelines, enable collaboration, improve quality, capture the full story of study, and pass inspections.

eTMF and TMF Services

Speed, scalability, peace of mind: Get industry-leading technology and/or services and stay inspection-ready.

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Content Management

Centralize your document collaboration and management from creation to archival in the eTMF.

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Trial Management

Speed site activation and improve oversight with remote site monitoring and mobile-first CTMS.

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Learning Management

Reduce risk with remote site and study personnel training. Automatically index training records in the eTMF.

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