Diamind Solutions

Document & Record Management: Simplifying Compliance and Collaboration

Managing documents and records is a cornerstone of clinical trial success, ensuring compliance, transparency, and efficient collaboration. The Document & Record Management module in the Diamind Clinical Trials Management Solution (DCTMS) offers a secure, centralized platform to streamline the creation, storage, and access of essential trial documentation. From regulatory compliance to real-time collaboration, this module is designed to meet the needs of modern clinical trials.

Key Features

  • Centralized Document Repository:
    • Store and organize all trial documents in one secure location.
    • Categorize files into folders, binders, or buckets for easy navigation and access.
  • Customizable Taxonomies:
    • Configure document schemas tailored to your trial needs, including OASIS-compliant structures.
    • Define mandatory, optional, and desirable documents for each trial or site.
  • Access and Permissions Management:
    • Implement role-based access controls to ensure secure document handling.
    • Restrict or grant access at document, site, or user levels.
  • Approval and Workflow Automation:
    • Enable submission, review, and approval workflows for efficient document management.
    • Track version histories and manage document expirations with automated alerts.
  • Regulatory Compliance:
    • Maintain an audit trail of document activities for inspections and regulatory submissions.
    • Adhere to global compliance standards, including FDA, EMA, and GCP guidelines.

Description

The Document & Record Management module in the Diamind Clinical Trials Management Solution (DCTMS) is designed to centralize and streamline the management of essential trial documents and records. By providing a secure, organized, and user-friendly platform, it ensures that all documentation is readily accessible while maintaining strict compliance with regulatory requirements. From initial trial setup to closeout, this module supports seamless collaboration among sponsors, sites, and stakeholders.

With customizable taxonomies and workflows, this module adapts to the unique needs of each trial. It allows users to organize documents using OASIS-compliant schemas or trial-specific structures, while automated workflows handle submission, review, and approval processes. Role-based access controls ensure that sensitive information is protected, while comprehensive audit trails provide transparency and accountability for every document interaction. Notifications and dashboards keep teams informed about missing, expiring, or pending documents, reducing the risk of compliance issues.

Integrated with other DCTMS modules, the Document & Record Management module eliminates data silos and fosters efficient collaboration across sites and regions. By combining robust security features with real-time access to documents, it empowers trial teams to focus on execution and insights rather than administrative tasks. Whether managing regulatory submissions, site-specific records, or trial-wide documentation, this module simplifies operations and enhances overall trial efficiency.

How It Works

  1. Document Storage and Organization:
    • Upload and store documents securely in the centralized repository, categorizing them for easy retrieval.
  2. Workflow Management:
    • Automate document submission, review, and approval processes, ensuring smooth collaboration across sites and stakeholders.
  3. Compliance and Monitoring:
    • Monitor document compliance with dashboards that highlight missing, expired, or pending files.
  4. Access Control and Security:
    • Define user roles and permissions to protect sensitive trial data and ensure secure access.

Why Choose Our Document & Record Management Module?

The Document & Record Management module simplifies the complex process of handling trial documents, ensuring that no file is overlooked and every workflow is optimized. By integrating seamlessly with other DCTMS modules, it offers a unified system for managing trial records, reducing administrative burdens, and improving collaboration among trial teams.

Enhancing Operational Efficiency

From initial setup to closeout, this module supports every phase of clinical trials with tools to maintain compliance and facilitate communication. It empowers sponsors, monitors, and site staff with real-time access to critical documents, enabling informed decision-making and efficient trial execution.

Streamline Your Document Management
Contact us today to learn how the Document & Record Management module can simplify your clinical trial workflows and ensure compliance.