eTMF
Fountayn’s eTMF is Part 11 compliant document repository with compliant audit logs and standardized terminology the eTMF Reference Model. Documents, workflows, and medadata are version controlled, centrally managed, and indexed. Users can be assigned roles for secure access. It is configurable by moving, copying, and deleting. Documents are searchable and exportable in formats conforming to the RM.
Regulatory inspection friendly with audit settings to tailor the viewable documents to information necessary and data definitions. Document data and workflows have settings for Quality Control, Certified Copy, Document Request, and more.
eTMF is closely integrated with Fountayn’s EDC to allow a seamless experience on platform without additional logins. Permissions can be grated to EDC users within the EDC dashboard allowing document sharing, upload document requests, workflow participation, and other features from eTMF.
Fountayn’s eTMF is priced at a fraction of what other eTMFs cost. Schedule your demo meeting with us to find out more.
Easy Mid-Study Change Implementation
We take pride in our one-of-a-kind process that can allow teams to implement changes without any required study downtime or data migration.
Randomization and Trial Supply Management
We support all types of protocol requirements while dispensing, controlling, and automating drug and treatment supply fulfillment.
Innovative Reporting
Powerful reporting gives study teams the ability to easily access, filter, and export real-time study data into clear and concise reports whenever they are needed.
Fountayn is dedicated to empowering our clients with an EDC solution that makes collecting trial data as simple as possible. Our goal is for our clients to have efficient and successful studies by using a platform made specifically with them in mind.
