Good Clinical Practice (GCP) guidelines are a cornerstone of clinical research, ensuring that trials are conducted ethically and scientifically, with the rights, safety, and well-being of participants as a priority. The International Council for Harmonisation (ICH) has recently released an…
The European Medicines Agency (EMA) plays a critical role in the regulation and approval of clinical trials within the European Union. In recent years, the EMA has updated its requirements for clinical trial submissions to ensure that trials are conducted…
The integration of digital health technologies (DHTs) into clinical trials represents a significant advancement in the field of medical research. From wearable devices to mobile health apps, these technologies offer new ways to collect data, monitor patient health, and improve…
