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OUR INSIGHTS

FDA draft benefit-risk assessment guidance - deadline for input 29th November
Lasse Schou Rasmussen
Posted by Lasse Schou Rasmussen
November 25, 2021

FDA draft benefit-risk assessment guidance - deadline for input 29th November

A key aspect of Clinigma’s work is capturing patients’ experiences for clinical development - before, during, and after clinical trials...

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EMA draft patient preference guidance - deadline for input 25th November
Lasse Schou Rasmussen
Posted by Lasse Schou Rasmussen
November 22, 2021

EMA draft patient preference guidance - deadline for input 25th November

Patient preference studies are a growing topic of interest for many different stakeholders (e.g. regulatory bodies, payers, industry, and patient organisations)...

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How patients' input can help to select the right PROs
Heather Rae-Espinoza
Posted by Heather Rae-Espinoza
October 25, 2021

How patients' input can help to select the right PROs

Trial results can rest on the appropriate selection of patient-reported outcomes (PROs), that are both sensitive enough to detect meaningful change yet targeted enough to limit participant and site burden...

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China's CDE Publishes a Draft of "Guiding Principles For Applying Patient-Reported Outcomes In Clinical Research"
Lasse Schou Rasmussen
Posted by Lasse Schou Rasmussen
October 18, 2021

China's CDE Publishes a Draft of "Guiding Principles For Applying Patient-Reported Outcomes In Clinical Research"

On September 3, 2021, China's Center for Drug Evaluation (CDE) published a draft of "Guiding Principles for Applying Patient-Reported Outcomes in Clinical Research...

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How to Coordinate Global Qualitative Interviews in Clinical Trials?
Lasse Schou Rasmussen
Posted by Lasse Schou Rasmussen
October 6, 2021

How to Coordinate Global Qualitative Interviews in Clinical Trials?

Let us be honest. Coordinating any kind of interviews involving several people besides the interviewee themselves is an activity that require close management and daily attention.

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Challenges in obtaining strong feedback from a clinical trial
Jens Harald Kongsø
Posted by Jens Harald Kongsø
August 9, 2021

Five challenges in obtaining strong feedback from clinical trials and ways to overcome them

When pharmaceutical companies have completed a clinical trial, they may want to organise a result meeting with the attendance of participating...

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