As clinical games emerge as a new tool for diagnosing and treating cognitive health, it is important to understand how these tools work and the ways in which these tools are validated, as well as how to realize their full potential.
An effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
The Cancer Research UK recently decided to have its Center for Drug Development adopt a risk-based monitoring approach across its entire portfolio of clinical trials.
After nearly five years of argument, the European Union's proposal to update its transparency directive for medicines has been dropped.
Building on more than a decade of initiatives to spur pediatric labeling on drugs and biologics, regulatory authorities are bolstering incentives for sponsors to develop more information faster on the use of medicines in children.
While the issue of adverse drug reaction (ADR) reporting is apparent in hospital systems, a deeper and uninvestigated problem resides within the process of ADRs: the patient.
Medidata took a look at how eCRF design complexity correlates with the number of migrations performed while a study is actively collecting subject data.