A valuable aid for clinical documentation management, developed to be fully digital and traceable, thanks to the creation of a collaborative environment for users involved in clinical trial management.
ICE eTMF is a validated, web-based software platform developed for the digital management of documents related to clinical studies. Documents can be uploaded, reviewed, approved, or rejected by users with specific roles. The platform enables centralized and secure document management, fully compliant with traceability and audit requirements in the clinical field.
ICE eTMF is available as a stand-alone system or as an integrated solution with ICE CTMS, offering maximum flexibility to meet diverse needs in clinical study management—including the ability to generate a new study directly from the CTMS.
Thanks to ICE eTMF, the traditional archive of paper copies is replaced by a digital repository with integrated version control and audit trails. The platform provides simplified access and navigation within a shared, collaborative environment, incorporating features that reduce the risk of errors and prevent the accidental loss of important documents.
ICE eTMF features
Easy and Remote Access
Accessible through the latest generation multi-platform browsers (MS Edge, Chrome, Firefox, and Safari);
Online Audit Trail
Monitoring all activities with a complete and detailed audit trail, ensuring maximum transparency and traceability throughout the management of documentation for the entire duration of the study.
Compliance
Designed in accordance with the "Trial Master File Reference Model Version 3.2.0 from November 2, 2020" proposed by the Drug Information Association (DIA);
Study Closure with Backup and Automated Management
Through specific workflows for study closure requests and related approval, it man-ages clinical trial closure securely and efficiently, automatically creating backup folders for the Sponsor and safely deleting documents that are no longer needed.
Multilingual Support for International Users
Makes the platform accessible to global teams with multilingual support to meet the needs of users worldwide;
UI Overview
Main features
User-friendly Interface
Intuitive interface, Automation, and Advanced Reporting
Optimizes clinical trial management through a platform with an intuitive interface, for quick and efficient analysis.
Multi-Tenant Web Application
A scalable, multi-tenant solution designed for centralized and secure clinical trial management, with advanced functionalities that improve operational control and resource allocation.
Centralized and Secure Document Management
A document management system compliant with security standards that ensures structured and protected file storage, accessible in a controlled manner by authorized users.
Standard and Custom Reports
Access meaningful data through both standard and customizable reports, designed to meet the specific needs of each clinical study and support decision-making.
Integration
Flexible Integration for Every Need
Available as an integrated solution with ICE CTMS or as a stand-alone system, offering maximum flexibility to meet diverse needs in clinical trial management.
Guaranteed Interoperability
Designed for seamless integration with EDC and eCRF, ensuring smooth and centralized management of clinical data through interoperable systems.
Remote Access
Complete Remote Access
Real-Time Updates from any Device any PC or Mac with an internet connection
Stay up to date wherever you are.
Receive instant updates from ensuring you’re always aligned with the progress of your clinical studies.
Data Quality and Compliance
Advanced Data Security
Data is protected with end-to-end encryption in transit, and secure access is enabled through two-factor authentication (2FA), ensuring robust defense against cybersecurity threats and maintaining the integrity and confidentiality of sensitive information.
Reliable and Traceable Document Flow
Every document modification is recorded in a detailed audit trail, including the date, time, and author of the change. This ensures complete traceability, maximum transparency, and full compliance with applicable regulations, guaranteeing the secure, controlled, and verifiable management of documents.
Adherence to Global Standards
The platform complies with the most stringent international standards, including GxP-GCP, GAMP 5, GDPR, HIPAA, FDA CFR 21 Part 11, and EU Annex 11, ensuring compliance with quality, security, and regulatory requirements throughout the clinical trial lifecycle.
Adaptability and Customization:
Modular and Flexible Solutions for Every Need
Offers highly configurable solutions, designed to adapt to the specific needs of each role, with dedicated permissions to ensure precise and secure control over operations. This approach optimizes efficiency throughout all stages of the clinical process.
Scalability for Studies of All Sizes
The platform supports studies of various sizes and types, including interventional and non-interventional studies. It is designed to handle multi-center studies, providing a smooth and integrated workflow, regardless of the complexity or scope of the project.
Efficiency and Cost Reduction
Optimized Document Management and Easy Access to the Digital Archive
Simplifies document management with an intuitive and easily accessible digital archive, optimizing workflows and increasing operational efficiency by reducing the time and resources dedicated to managing physical documents.
Quick Configurations and Flexible Communication
Configure the platform quickly and efficiently to meet the specific needs of your study. The integrated communication system between roles facilitates continuous and optimized coordination between the teams involved.
Cost Savings and Reduction of Expenses
Significantly reduce management costs compared to traditional archives. Advanced security and the digital centralization of documents help reduce the risk of loss and improve resource control, leading to substantial cost savings.
SUPPORT AND TRAINING
Continuous Customer Support & Multilingual Assistance
Our multilingual support team is always available, with a ticketing system that ensures fast and effective resolution of incidents and requests.
Personalized Onboarding & 24/7 Knowledge Base Access
We offer tailored onboarding sessions to accelerate platform adoption, along with 24/7 access to our dedicated Knowledge Base to support you at every stage.
Regular Updates & Continuous Improvements
We consistently release new features based on customer feedback, along with bug fixes and security updates, to ensure an optimal and ever-evolving user experience.