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

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...

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)...

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...

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.

How to ensure patient safety during clinical trial interviews
Lasse Schou Rasmussen
Posted by Lasse Schou Rasmussen
May 13, 2021

How to ensure patient safety during clinical trial interviews

Despite the many positive aspects of interviewing patients to inform the drug development, there can still be a reluctance within pharmaceutical companies to start collecting direct patient feedback in their clinical trials.