Over recent years global drug companies large or small have recognized that one root cause of the high failure rate in their clinical development lies in the selection of right therapeutic targets.
The concept of risk-based monitoring (RbM) is evolving, as nonprofit organizations continue to collaborate with the biopharmaceutical/medical device industry to investigate, pilot and implement RbM practices.
By Erica Heath
The idea is great: when an investigator submits a grant to any NIH institute, if the study will involve more that one performance site, the grant must include a plan to rely on one single IRB.
Medidata took a look at how eCRF design complexity correlates with the number of migrations performed while a study is actively collecting subject data.
Tufts CSDD estimates that the cost to develop a new prescription medicine that gains marketing approval is now $2.6 billion.