SureETMF

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SureETMF is a cloud-based electronic Trial Master File solution designed to streamline the management of clinical trial documents and data. It enables biotechnology and pharmaceutical organizations to capture, collect, share, view, digitally sign, store, and manage documents, medical images, videos, clinical trial data, and other electronic content essential for medical research. Key Features and Functionality: - Comprehensive Document Management: Facilitates the organization and retrieval of clinical trial documents, ensuring they are audit-ready and compliant with regulatory standards. - Digital Signing and Workflow Automation: Integrates digital certificate signing and automated workflows, allowing for efficient document completion and approval processes. - Mobile Accessibility: Offers a mobile-first design compatible with web browsers, Apple iOS, and Android devices, enabling users to access and manage documents anytime, anywhere. - Compliance and Security: Provides out-of-the-box compliance validation for FDA 21 CFR Part 11, EC Annex 11, and HIPAA, ensuring secure and compliant handling of sensitive clinical trial data. Primary Value and User Benefits: SureETMF addresses the challenges of managing extensive clinical trial documentation by digitizing and automating processes, thereby reducing reliance on paper-based methods. This leads to enhanced efficiency, improved collaboration among stakeholders, and accelerated project completion milestones. By ensuring regulatory compliance and offering secure, mobile access to critical documents, SureETMF empowers clinical operations teams to focus on delivering innovative therapies to patients more swiftly.