Brussels Metropolitan Area
Learn more about Allyfe at www.allyfe.health Allyfe’s platform consists of two major components: a patient enrolment solution and a regulatory document management system. The patient enrolment journey has been designed with patients, researchers and trial sponsors. Its web and mobile applications support researchers and sponsors by shortening time to market, massively reducing administrative workload, facilitating collaboration and making it easy, secure and more engaging for patients to participate in clinical trials. The regulatory document management system includes a Study Start-Up module, a digital Investigator Site File (e-ISF), and a fully integrated electronic Trial Master File (e-TMF) 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.
At Allyfe, I lead the vision, strategy, and execution of a digital health platform designed to simplify and accelerate clinical trials. Our modular solution addresses two critical needs in the research ecosystem: Patient Enrolment: Streamlining recruitment and data collection across diverse clinical settings. Regulatory Document Management: Providing a compliant, high-quality eTMF and eISF system with built-in audit trails, role-based access, and long-term archiving. We serve sponsors, CROs, and sites with a user-friendly platform that is secure, flexible, and aligned with global regulatory standards (FDA 21 CFR Part 11, EU Annex 11, ICH-GCP, GDPR). I work closely with product, compliance, and clinical teams to ensure that Allyfe delivers measurable value and operational excellence to every stakeholder involved in clinical research.
Project Management and Information Systems applied to business process re-engineering in Pharma.
Working as an external consultant
Working as an external consultant
Working as an external consultant
Working as an external consultant