Biostatistics
What is a parameter or variable?
What do statisticians mean when they talk about parameters or variables? In the frame of a clinical study, a variable is something that can be
Clinical Research Insights
What do statisticians mean when they talk about parameters or variables? In the frame of a clinical study, a variable is something that can be
It is a widely spread view that biostatisticians should be involved only after data has been collected. But involving a biostatistician already in the planning
A medical writer is responsible for producing well-structured documents presenting scientific, clinical, educational, or promotional information clearly and concisely. In clinical trials, delivery of these
Medical writers communicate clinical data and various findings in medicine to a wide range of audiences and within the scope of a number of different
Medical writing offers an opportunity to learn about various health fields, medical conditions, as well as drugs, medical devices and treatments. There is a wide
An essential, and often overlooked part of the work on clinical trials is medical writing. It is involved at the start and end of the
The new MDR requires small to midsize medical device companies to take over sponsor responsibilities for their clinical trials. Some companies find they cannot take
ICH GCP and ISO14155 defines the term monitoring as “The act of overseeing the progress of a clinical trial, and of ensuring that it is
“Is it equivalent?” As a medical device manufacturer, you are very aware of MEDDEV 2.7/1 rev. 4. from 2016. Following this document when planning and
ICH GCP and ISO14155 defines the term monitoring as “The act of overseeing the progress of a clinical trial, and of ensuring that it is