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Best Regards, The Allyfe Team.
Best Regards, The Allyfe Team.
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Allyfe unifies the full spectrum of trial operations-from study start-up and site activation to e-ISF, e-TMF, and compliant long-term e-archiving - all within a single, modular integrated environment.
Our e-TMF is not a silo-it acts as the backbone, integrating with clinical systems like, EDC, e-Regulatory, and ISF. We support custom connectors and vendor coordination to ensure interoperability.
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Clinical Monitors can perform real-time remote QC across ISF and TMF, dramatically reducing document cycle times and reconciliation delays.
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Priced competitively to offer exceptional value compared to other solutions on the market
GenAI automates monitoring, procedural controls, and anomaly detection, while enabling auto-classification of regulatory documents—amplifying precision, timeliness, and scalability.
Allyfe offers a document management system built for Biotechs, Clinical Sites and CROs. It includes a Study Start-Up (SSU) module, a digital Investigator Site File (e-ISF), and a fully integrated electronic Trial Master File (e-TMF), a compliant e-archive solution, all aligned with the DIA TMF Reference Model. A key differentiator is its ability to enable CRAs to perform remote Quality Control (QC) on both the ISF and TMF—this helps significantly reduce document cycle times and reconciliation efforts.
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.
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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
