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On September 29, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance for the industry entitled "Benefit-Risk Assessment for New Drug and Biological Products" to clarify how...
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
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
Patient preference studies are a growing topic of interest for many different stakeholders (e.g. regulatory bodies, payers, industry, and patient organisations)...
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...
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...