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Best Regards, The Allyfe Team.
Best Regards, The Allyfe Team.
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Build a unified, inspection-ready documentation ecosystem across SSU, ISF, eTMF, and Archiving.
Helping you choose, assess, and manage clinical technology vendors with confidence.
Designing the digital backbone of your clinical trial operations. Ensure every system, workflow, and integration supports compliance, scalability, and real-world trial execution.
Allyfe offers a comprehensive advisory service that supports Sponsors, CROs, and biotech companies in designing and operationalizing a fully compliant, inspection-ready documentation strategy across the entire trial lifecycle—from Site Start-Up to e-Archiving.Our experts guide you in structuring and aligning processes across SSU, digital ISF, eTMF, and long-term archiving, ensuring consistency, regulatory compliance, and clarity of responsibilities across all stakeholders.We help you define documentation strategies, implement remote quality control models, and harmonize SOPs to support digital workflows and cross-system integration. Whether you're onboarding new sites or preparing for regulatory inspections, we ensure your document ecosystem is scalable, streamlined, and ready for real-world demands.This end-to-end advisory offering ensures Allyfe isn’t just implemented—it’s fully optimized to strengthen compliance, reduce operational risk, and accelerate trial execution.
Allyfe provides expert guidance to Sponsors and CROs in evaluating and selecting clinical trial vendors through a structured, compliance-focused approach. We support you in defining selection criteria tailored to regulatory expectations and operational needs, ensuring each vendor aligns with your digital trial strategy. Our team helps assess vendor readiness through documented risk evaluations, qualification reports, and audit frameworks that stand up to regulatory scrutiny.We also guide the due diligence process—from data protection and security controls to interoperability and workflow integration—ensuring vendors can be seamlessly incorporated into your trial infrastructure. Whether you're qualifying an EDC system, an eCOA platform, or any other digital solution, Allyfe ensures your vendor ecosystem is reliable, compliant, and fully aligned with your clinical and operational goals.Patient dropout is a costly problem for clinical trial sponsors, who have consequently focused their attention on patient retention factors and on its corollary, patient engagement. It is widely believed that patients’ early and continued involvement throughout a study can indeed prevent dropout and lead to faster time to market at lower costs. To respond to that patient retention need, Allyfe can devise a specific engagement plan for your clinical trial.
Allyfe offers strategic advisory to help Sponsors, CROs, and biotech companies architect a cohesive, future-ready clinical technology ecosystem. We work with your teams to map out how digital tools—including SSU, ISF, eTMF, CTMS, and EDC—fit together across your trial workflows, ensuring interoperability, regulatory alignment, and operational efficiency.Our approach focuses on designing scalable, modular architectures that reflect your specific trial models—centralized, hybrid, or decentralized. We help define the role of each system within the broader documentation and data flow, clarify user roles and permissions, and identify where integrations or automation can drive efficiency.Whether you're digitizing for the first time or optimizing an existing setup, Allyfe ensures your clinical tech stack is not only compliant, but strategically aligned with your operational goals and ready to support trials at scale.
