Insights on Patient-Focused Drug Development (PFDD) OUR INSIGHTS LEARN MORE Contact Us We share our insights to keep you updated on patient engagement initiatives, trends, and regulatory guidelines Down arrow icon

OUR INSIGHTS

Jens Harald Kongsø
Posted by Jens Harald Kongsø
January 18, 2022

FDA draft benefit-risk assessment guidance - a cancer treatment perspective

On September 29, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance for the industry entitled "Benefit-Risk Assessment for New Drug and Biological Products" to clarify how...

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Clinigma® recognised as one of the top 10 European companies providing clinical trial management solutions
Lasse Schou Rasmussen
Posted by Lasse Schou Rasmussen
December 14, 2021

Clinigma recognised as a Top 10 European company in providing clinical trial management solutions

We are honoured to have been awarded and recognised by Pharma Tech Outlook as one of the top 10 European companies providing clinical trial management solutions for pharmaceutical companies

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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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