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

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.

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

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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Trial Management

Site Solutions

Content Management

Learning Management

Quality Management

eClinical Platform

TMF Services

IT and Quality Services

Training and Education

ClinOps

Regulatory

Quality

IT

Navigating Site Challenges: How to Stay Focused on What Matters

Reducing Risk for Regulatory Professionals

Achieve Global Regulatory Compliance

Global Support for Regulatory Documents and Submissions

Enable Cross-Functional Collaboration and Real-Time Audit Preparedness

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.