OUR INSIGHTS
EMA wants to strengthen the collaboration with HTAs to reinforce patient relevance in evidence generation
Highlights on EMA’s focus to advance patient-centred access to medicines in partnership with healthcare systems. In EMA’s Regulatory Science Strategy to 2025, the EMA presents...
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Patient-centred drug development in EMA's Regulatory Science Strategy to 2025
Increased interest from EMA to enhance the incorporation of patients’ voices into drug development. As part of the EMA’s Regulatory Science Strategy to 2025, EMA proposes…
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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…
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Why PROMs do not guarantee a full picture of patients’ experiences with new drugs
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…
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Can you afford to launch a new drug without hearing what patients think about it?
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…
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Introducing the Clinigma® Portal
An IT portal facilitating secure and easy collection of trial patient feedback. Patient insights and experiences are critical for pharmaceutical companies to successfully bring new drugs to market…
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