eTMF Clinical Trials

• More than 10 years of utilizing eTMF in our services: We have utilized electronic Trial Master File software to streamline and optimize our trial management processes for more than a decade. This powerful electronic system ensures the highest standards of documentation, compliance, and data integrity, which are crucial for meeting EMA, FDA and other regulatory requirements.
• Efficient handling of all trial-related documents and data: Our long-standing use of eTMF reflects our expertise in generating high-quality documentation and record-keeping while at the same time reducing administrative burdens and time consuming manual workflows.
• In House Design and Planning by eSolutions department: Utilizing internal resources to set up and manage our eTMF contributes to the responsiveness and adaptability to project workflows. We offer the eTMF by industry-renown Software companies Veeva and Flex Databases.

An eTMF allows us to manage vast amounts of trial documentation with precision. By leveraging this advanced software, we ensure that all trial documentation is accurate, up-to-date, and easily accessible at any time. This is particularly important for maintaining comprehensive and compliant records that meet EMA and FDA standards.

With an eTMF, the sponsor and CRO can monitor and manage clinical trials even more efficiently, significantly reducing the time and effort required for document handling. The digital format allows authorized users remote access from any location. Workflow automation allows multiple users to review, annotate, and approve documents simultaneously. Integrated notifications and alerts facilitate timely completion of tasks. This can greatly improve real-time collaboration across geographically dispersed teams. An eTMF comes with built-in automated tracking and version control capabilities. This enables better tracking of document histories, easy access to previous versions, and a clear audit trail for each document change. The system's robust features streamline the processes of filing, and retrieval, leading to enhanced quality and consistency in clinical research documentation.

Using an eTMF facilitates audit readiness with real-time status reporting, digital audit trails, and easy retrieval of documents. An eTMF is typically organized using a digital structure aligned with regulatory and industry standards (e.g., TMF Reference Model). Regulatory authorities can access an eTMF remotely, and the digital audit trail offers transparent tracking of actions on each document.

Digital security measures such as encryption, role-based permissions, and access control ensure better protection of data. Regular backups reduce the risk of loss.

The eTMF system provides robust monitoring and reporting capabilities, enabling the clinical research team to track the progress of trials in real-time. This visibility helps us identify and address any issues promptly, ensuring that trials stay on track and within regulatory compliance.

Our eTMF solutions (electronic Trial Master File) are advanced cloud-based document management systems specifically designed for the clinical research industry. The eTMF serves as a centralized repository for all essential clinical trial documents, ensuring comprehensive management of trial-related data and facilitating compliance with regulatory standards. The eTMF streamlines the entire trial lifecycle, from planning and initiation through to execution and closeout, providing a robust framework for managing documentation, data integrity, and regulatory compliance.

The advantages are:

• Centralized Document Management: We offer a single, secure location for all trial-related documents. This centralization of the eTMF ensures that documents are easily accessible, accurately maintained, and consistently organized. The system supports a wide range of document types, including protocols, patient consent forms, monitoring reports, and regulatory submissions.
• Real-Time Collaboration and Access: Our eTMF systems enable real-time collaboration among clinical trial stakeholders, including sponsors, CROs, and regulatory authorities. With role-based access controls, users can securely view, edit, and manage documents from any location, enhancing collaboration and ensuring that the most up-to-date information is always available.
• Automated Workflows and Process Management: An eTMF automates many of the manual processes involved in clinical trial management, such as document routing, review, and approval. This automation reduces administrative burden, minimizes errors, and accelerates the overall trial process. The system's configurable workflows ensure that documents move seamlessly through their lifecycle, adhering to predefined processes and timelines.
• Comprehensive Audit Trails: Maintaining a clear and auditable record of all trial activities is crucial for regulatory compliance. Our eTMF provides detailed audit trails that track every action taken within the system, from document creation and modification to user access and approvals. This transparency supports rigorous regulatory inspections and internal audits.
• Regulatory Compliance: The eTMF system is designed to comply with global regulatory standards, including those set by the FDA, EMA, and other health authorities. It facilitates smoother submission processes and reducing the risk of non-compliance.
• Advanced Reporting and Analytics: The eTMF includes powerful reporting and analytics capabilities, enabling users to generate real-time insights into trial progress, document status, and compliance metrics. Customizable dashboards and reports provide a comprehensive view of trial activities, helping stakeholders make informed decisions and identify areas for improvement.

Our commitment to using cutting-edge technology ensures that we remain at the forefront of clinical trial innovation, providing exceptional value to our clients and contributing to the advancement of medical science. By choosing FGK Clinical Research, you are partnering with a CRO that prioritizes quality AND efficiency.

Find out more: All of FGK’s eSolutions

Contact FGK today to learn more about our clinical trial services and how our eTMF solutions can enhance your research projects.