On September 29, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance for the industry entitled "Benefit-Risk Assessment for New Drug and Biological Products" to clarify how...Read More
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 companiesRead More
A key aspect of Clinigma’s work is capturing patients’ experiences for clinical development - before, during, and after clinical trials...Read More
Patient preference studies are a growing topic of interest for many different stakeholders (e.g. regulatory bodies, payers, industry, and patient organisations)...Read More
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...Read More
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...Read More