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 [...]
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 [...]
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 [...]
SaMD, artificial intelligence and machine learning: regulators’ first steps
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 [...]
Clinical trials, how biomarkers help research
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 [...]
CYBERSECURITY FOR MEDICAL DEVICES: PROTECTING YOURSELF FROM RISKS WITH BLOCKCHAIN
Cyber attacks can cripple the operation of systems in any sector. However, in the case of health care, such paralysis can be a matter of life and death. Recently, medical device security has become a global concern and a [...]
CAREERS IN CLINICAL DEVELOPMENT: PHYSICIANS OF 2030
Health care is connected to every aspect of society. We rely on highly qualified physicians to keep us healthy by using their vast knowledge and progressively more advanced clinical tools and resources. But physicians around the world involved in [...]
SOLVING THE DATA MANAGEMENT CHALLENGE IN DIGITAL CLINICAL TRIALS
When novel drugs or medical devices are evaluated in clinical trials, the data generated in this process is called clinical data. Improving the use of technology in clinical trials is now a prime opportunity for the life sciences industry. [...]
CLINICAL TRIAL DESIGN: THE REVOLUTION OF NEW STATISTICAL PRINCIPLES
Edited by Dr. Monica Tocchi, Meditrial medical director. The organization called ICH (International council for harmonization of technical requirements for pharmaceuticals for human use) is a global organization that unites regulatory authorities and the pharmaceutical industry in the common [...]
