eTMF by GBA Key2Compliance - Simplify, Comply, Succeed
Our user-friendly eTMF system simplifies clinical study documentation by providing a fully compliant, cloud-based solution that enables efficient document management, secure collaboration, and unlimited study flexibility.
What is an eTMF?
An electronic Trial Master File (eTMF) is the cornerstone of efficient and compliant clinical studies. It serves as a centralized, digital repository for all essential documents related to a clinical study. By transitioning to an eTMF, you streamline document management, improve regulatory compliance, and ensure seamless collaboration between stakeholders.
Our cloud-based eTMF solution, powered by Focalcube, is fully aligned with ISO 14155:2020 and ISO 20916:2019 standards, guaranteeing compliance while enhancing operational efficiency.
Why Choose Our eTMF?
At GBA Key2Compliance, we offer a subscription-based eTMF platform that lets you create and manage unlimited studies – all within a single, user-friendly system.
Unlike traditional eTMFs that charge per study or restrict usage, our model gives you full flexibility: one license, unlimited eTMFs, and complete control.
Here’s what sets us apart:
- Effortless Setup & Scalability: Get a fully functional eTMF structure set up quickly, with flexible license options ranging from 5 users to 100+ users.
- Regulatory Compliance: Built to meet ISO 14155:2020 and ISO 20916:2019 standards, ensuring your studies align with global regulatory expectations.
- FDA Part 11 Approved e-Signing: Secure and compliant electronic signatures for a paperless workflow.
- Unlimited Storage & Study Management: Conduct multiple studies without limitations on document storage and manage access control easily within your organization and with stakeholders.
- Seamless & Secure Document Handling: Easy document uploads, direct mailbox integration, and simple exporting for efficient archiving, all while maintaining the highest security.
- Expert Support & Training: Benefit from one-on-one training sessions with our Clinical Trial Assistants (CTAs), and continuous support when needed, ensuring you are equipped to use the system effectively.
Go paperless today and reduce your carbon footprint by digitizing your study files, contributing to a more sustainable research process.
How is Our eTMF Implemented?
Our implementation process is designed for efficiency, ensuring you can start using the system with minimal disruption:
- eTMF Setup: We configure the Focalcube platform to meet your study requirements, delivering a fully operational eTMF structure tailored to your needs.
- Training & Onboarding: Our expert Clinical Trial Assistants provide a 1-hour training session to ensure your team can navigate and utilize the system with confidence.
- Ongoing Support & Customization: Whether you need document filing assistance, structural customization, or digital archiving solutions, we offer continuous support to keep your eTMF optimized for success.
With our eTMF, you don’t just get a system—you get a strategic partner in clinical study compliance and efficiency.
Get Started Today
Modernize your clinical study documentation with GBA Key2Compliance. Contact us today to discover how our eTMF solution can elevate your study management.