OUR INSIGHTS
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
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
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"
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?
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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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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