CLINIGMA

Patients should be meaningfully involved throughout the medical product development process – as partners who are experts in their own experience of their disease or condition and the ultimate consumers of medical products. Recent guidance issued by the US Food and Drug Administration (FDA) recognises that the collection of patient experience data is important because it provides an opportunity to inform medical product development and enhance regulatory decision-making to better address patients’ needs. Who we are Clinigma®, previously known under the name Clinical Survey Outcomes, has the expertise to assist pharmaceutical companies who wish to comply with the FDA’s advice on how to collect and submit data. Our team of qualitative researchers are highly-skilled at capturing comprehensive and representative patient input and synthesising this feedback into relevant insights in a way that can inform the development process. How we work We achieve this by conducting in-depth interviews with patients participating in clinical trials (entry/exit interviews) and setting up tailormade questionnaires in relation to clinical trials (entry/exit interviews). The outcomes of our research can be used to get a better picture of the patients in the trial, to remove uncertainties surrounding the product profile, improve the outcomes strategy, sharpen marketing efforts and most important to have the answers ready when FDA asks for patients experience data. Clinigma® also provides qualitative research work in real-world settings and has access to one of the strongest patient, physician and key opinion leader (KOL) panels in the industry. Our real-world research work is often conducted to support our clients in showing the important relation between patient experiences in random clinical trials (RCTs) and real life. Our vision is to bring clarity and value to the pharmaceutical companies we work with by being their trial patients´ structured voice.