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 [...]

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 [...]

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 [...]

Dr.ssa Paola Antonini, Meditrial scientific director The International medical device regulators forum (Imdrf), describes Software as a Medical Device (SaMD) as software that can run on generic (non-medical) computing platforms. They can be used in conjunction with other [...]

Dr.ssa Paola Antonini, Meditrial scientific director In recent years, the field of biomarkers in research and clinical practice has shown remarkable progress. These tests can be used in the screening, diagnosis, characterization, and monitoring of diseases; as prognostic [...]