INSIGHTS

In this section, we are regularly sharing relevant information on patient-focused drug development.

Patient-centred drug development in EMA's Regulatory Science Strategy to 2025
Laura Lassen
Posted by Laura Lassen
October 16, 2020

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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Patient-Focused Drug Development Guidance
Laura Lassen
Posted by Laura Lassen
October 9, 2020

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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Limitations of Patient Reported Outcome Measures (PROMs)
Laura Lassen
Posted by Laura Lassen
October 2, 2020

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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Hearing patients' experiences in clinical trials
Laura Lassen
Posted by Laura Lassen
September 25, 2020

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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Clinigma Patient Interview Portal
Laura Lassen
Posted by Laura Lassen
September 4, 2020

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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The new Clinigma website
Laura Lassen
Posted by Laura Lassen
August 31, 2020

Our new website is live!

Visit the new Clinigma® website today. We are very excited to announce that our new and refreshed website www.clinigma.com is now live. The updated site includes all the information you need to learn more…

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