Sapienza University launches the Sarcopenic Obesity e-Registry in partnership with BlueCompanion

Rome, 15 October 2024 — The Department of Experimental Medicine at Sapienza University in Rome, and specifically the Food Science Research Unit, has initiated and is leading a collaborative project for the clinical implementation of ESPEN-EASO criteria for diagnosis and staging of Sarcopenic Obesity (SO) — a Research Project of National Interest (PRIN 202229ET3S).

The Sarcopenic Obesity e-Registry is developed in partnership with BlueCompanion, a company specialised in digital services for the health and clinical research sector. The initiative is fully endorsed by SOGLI (Sarcopenic Obesity Global Leadership Initiative) and by the Italian Society for the Study of Obesity.

The database — collecting demographic and comprehensive clinical data on patients with Sarcopenic Obesity — is operationalised on a new digital platform designed and managed by BlueCompanion. Key features include regulatory compliance (US FDA 21 CFR Part 11, EU GDPR, ICH E6 GCP), data security, infrastructure and data hosted in Europe (UK and France), and readiness for integrating new eCRFs for clinical trials.

The e-Registry is a collaborative tool boosting clinical research: it enables epidemiological insights, treatment-effectiveness evaluation, faster clinical-trial recruitment, evidence-based clinical guidelines, patient empowerment and regulatory dialogue on factual bases.

Lorenzo Maria Donini, Initiator and Principal Investigator, explained: «We are happy to have undertaken a collaboration with BlueCompanion. The significant skills put into play in this phase will certainly allow us to widely establish the Sarcopenic Obesity e-Registry, which will be very useful and will become essential in the years to come.»