Allyfe offers a comphrehensive document management solution for your clinical trial - from site start-up to e-ISF, e-TMF, and compliant long-term e-archiving - all within a single, modular, integrated environment.
Our e-TMF is not a a standalone system-it functions as the backbone of your clinical ecosystem, integrating with systems like e-Regulatory, and e-ISF. We provide flexible integrations and handle vendor coordination to ensure your systems work seamlessly together.
Clinical Monitors can perform real-time remote QC across ISF and TMF, dramatically reducing document cycle times, reconciliation delays, and travel costs. The platform also enables online validation, giving teams immediate insight into document status and compliance.
Our solution is priced competitively to deliver exceptional value. Allyfe offers the same high quality and operational excellence as leading solutions—at a significantly more accessible cost. We offer flexible pricing models designed to adapt to diverse operational needs and budgets.
Allyfe offers Gen AI to automate document controls and anomaly detection while enabling auto-classification and meta-data creation of regulatory documents. We are committed to amplifying precision and ready to evolve with your business in a timely and scalable way.
Allyfe offers a smart, modular document management platform designed for Sponsors, CROs, and Clinical Sites. Our flexible system spans Site Start-Up (SSU), digital Investigator Site File (ISF), and electronic Trial Master File (eTMF), including a compliant archiving solution. This modularity allows clients to use Allyfe as a standalone system or integrate it seamlessly into existing workflows—supporting both clinical trial execution and long-term archiving needs. All modules adhere to strict security and regulatory standards and are fully aligned with the DIA TMF Reference Model. Allyfe ensures high-quality, compliant document management with real-time monitoring and built-in quality control—all within an intuitive, user-friendly interface.
Remote Site Activation involves the digital distribution, processing, storage, collection, and electronic signing of all regulatory start-up documents required to onboard site personnel, submit regulatory binders and activate research sites efficiently.
Sites manage all document workflows in one single application. End-to-end document workflows and automation helps sites break operational bottlenecks while providing real-time visibility on documents completion. Sponsors can react instantly in case of lowering performance and communicate with research sites.
Traditionally, CRAs travel to individual sites to review regulatory documents, procedures, and source data. With Allyfe’s remote quality control module, CRAs can now log into the Allyfe portal to audit workflows, check for completeness, timeliness, and protocol adherence—all from anywhere. They can raise queries, leave notes, and guide sites on next steps, streamlining the monitoring process.
The Allyfe Electronic Trial Master File (eTMF) combines intuitive workflows with smart automation to ensure a consistently inspection-ready system. Its integrated design serves as a central hub for clinical operations, particularly when connected with other systems such as eCRF, SSU, eISF, and CTMS. Allyfe also supports the development of custom connectors to seamlessly integrate with third-party platforms of your choice.Â
Data Archiving as a Service streamlines regulatory compliance by securely retiring system applications and archiving closed studies. Your data and documents stay accessible throughout the retention period, fully aligned with your organization's data governance policies. The Allyfe eTMF archive solution drastically reduces the cost to comply with ICH GCP, FDA, and EMEA document retention requirements.
As a tech-driven organization, we modernise the R&D IT applications for biopharma within the clinical development tech stack that are responsible for capturing experimental data and managing trial operations. Â Â