DMS

AQ-Trials' DMS (Document Management System) is a cloud-based clinical document management solution designed for organisations involved in clinical trials, including sponsors, CROs, and trial sites. It is built to simplify document processes, support regulatory compliance, and reduce the administrative burden associated with managing trial-related documentation throughout the drug development lifecycle.

The platform is validated for regulatory compliance and meets 21 CFR Part 11 standards, aligning with requirements set by the MHRA, FDA, and EMA. It combines document storage, version control, collaboration tools, and learning management capabilities within a single unified platform.

Core Features

• Centralised Document Storage: Provides a secure, cloud-based repository for all trial-related documents, accessible by authorised personnel from any location at any time. Includes an archiving function for organised data storage and retrieval.
• Advanced Search Capabilities: Supports full-text search to allow users to locate documents quickly, reducing time spent on document retrieval and improving operational efficiency.
• Automated Version Control: Manages document versions to maintain accuracy and consistency across trial documentation.
• Robust Security and Compliance: Fully validated to meet 21 CFR Part 11 standards, ensuring data integrity and security in line with MHRA, FDA, and EMA regulatory requirements.
• Document Collaboration and Sharing: Supports controlled access, commenting, and document sharing to facilitate review and approval processes among relevant stakeholders.
• Learning and Compliance Tracking: Includes customisable learning paths, progress tracking, certification management, and compliance tracking to support staff competency and adherence to regulatory requirements.
• All-in-One Platform: Offers a unified solution providing a 360-degree view of regulatory obligations, designed to streamline workflows and support decision-making across trial operations.

Benefits

• Increased Efficiency: Automates and streamlines clinical content management, reducing manual tasks so teams can focus on critical trial activities.
• Enhanced Compliance: Supports adherence to regulatory requirements through automated workflows, audit trails, and secure document management.
• Improved Collaboration: Facilitates communication and document sharing among trial sites, sponsors, and CROs.
• Reduced Risk: Minimises the risk of errors, document loss, and non-compliance through centralised storage, version control, and controlled access.
• Scalability: The cloud-based architecture allows the system to scale to accommodate clinical trials of varying sizes, complexity levels, and geographic reach.

AQ-Trials' DMS is delivered as a cloud-based platform and is positioned as part of a broader all-in-one clinical trial management offering. It is suitable for organisations seeking a validated, regulation-aligned system for managing patient records, trial documentation, and staff compliance training within a single environment.