A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on in clinical research. The WHO [...]
Il contributo delle associazioni pazienti negli studi clinici
In collaborazione con Aboutpharma Storicamente, le organizzazioni dei pazienti hanno avuto lo scopo primario di supportare le comunità che rappresentavano. Oggi questa rimane una funzione cruciale ma le modalità sono cambiate, come anche il ruolo che le [...]
The importance of the Data Monitoring Committee in the trials of today and tomorrow
Dr. Paola Antonini, Meditrial Scientific Director All clinical trials benefit from oversight, which is currently provided by regulatory authorities, Ethics Committees or Institutional Review Boards, and Data Monitoring Committees (Dmc), also sometimes referred to as Data Safety Monitoring [...]
L’importanza del Data Monitoring Committee nei trial di oggi e domani
D.ssa Paola Antonini, direttore scientifico Meditrial - IN COLLABORAZIONE CON ABOUTPHARMA Tutti gli studi clinici beneficiano di supervisione, che attualmente è fornita dalle autorità regolatorie, dai Comitati Etici o dalle Institutional Review Board, e dalle Data [...]
Studi di fattibilità precoce sui devices: “fare prima” per evitare il fallimento dei trial
Paola Antonini, direttore scientifico Meditrial - IN COLLABORAZIONE CON MEDITRIAL Si stima che oltre il 90% degli studi clinici fallisca a causa di un limitato reclutamento dei pazienti, inefficienze dello sperimentatore, insufficiente comprensione degli aspetti etici e [...]
Early feasibility studies on devices: “doing it sooner” to avoid trial failure
Paola Antonini, Meditrial Scientific Director. It is estimated that more than 90% of clinical trials fail due to limited patient recruitment, investigator inefficiencies, insufficient understanding of local ethical and regulatory aspects, site and region selected for conducting the [...]
