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 – led by the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) – are acknowledging the value that patient feedback can contribute to medical product development. As part of an effort to enhance the incorporation of the patient’s voice in clinical trials, FDA has developed Patient-Focused Drug Development (PFDD) guidances, and EMA will start developing similar guidances following the EMA Regulatory Science Strategy 2025.
What does Clinigma® offer?
Clinigma® supports pharmaceutical companies in Patient-Focused Drug Development (PFDD) by providing expert solutions to capture patient feedback in clinical trials. This includes supporting pharmaceutical companies in obtaining valuable qualitative insights into the safety and efficacy of investigational drugs, which can be used as additional arguments for regulators’ approval of a treatment.
About Clinigma®
Clinigma®, previously known as Clinical Survey Outcomes, is the only research company in the world with a 100% focus on patient interviews in clinical trials. The company was founded in 2017 and is headquartered in Copenhagen, Denmark. With its expertise, a unique IT portal, and a large global network of qualitative researchers (200+ researchers and 70+ different languages), Clinigma® is at the forefront of its field of interviewing patients in clinical trials.
