Are you developing drugs in accordance with regulatory guidances on Patient-Focused Drug Development?
The FDA and the EMA are strengthening Patient-Focused Drug Development. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both acknowledge that…Read More
The limitations of Patient Reported Outcome Measures (PROMs). Traditional PROMs (consisting of closed-end questions) have for many years been applied to reveal the patients’ experiences of effects…Read More
Get the full picture of a treatment. To ensure that you get a clearer picture of a treatment, we recommend interviewing the users who are exposed to a drug candidate as early as possible in the trial…Read More
Increasing use of qualitative research methods in clinical trials. At Clinigma®, we are not the only ones recognizing the value of listening to the patients in clinical trials. Increasingly, regulatory agencies…Read More