Traditionally, health data has been generated by documenting patients’ records (i.e. clinicians’ notes, lab results, prescriptions etc.) in a paper-based system. However, this system has several challenges such as...
Digital health technologies (DHT) can be deployed over a broad range of use in healthcare. This entails different approaches in their regulation and the assessment of their benefits, risks,...
Introduction This is a collaboration between Bristol-Myers Squibb (BMS) with FUNDHEPA (patient organisation) to give more patients the opportunity to receive an innovative treatment for Hepatitis C through the...
Transcript * this transcription has been done with the help of AI. What is a clinical research study? For many of us, being diagnosed with a serious...
Medicines must balance efficacy and safety, benefits and risks. The efficacy and safety of a medicinal product are tested thoroughly during its development, and carefully monitored after the product...
Introduction An example of patient’s own experience of being used as an interface between sponsors and participants of clinical trials. Taking place both in rare diseases with EURORDIS and...
Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes...
Phase I trials are usually the first studies of a medicine conducted in humans – known as ‘first-in-human’ (also known as first-in-man) trials. They are typically human pharmacology studiest,...
Patient advocates can be involved in early clinical development through partnerships and working relationships with regulatory authorities, ethics committees, investigators, and industry. They can provide input and play an...
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