Subject Profile Analyzing Risk Saves Time for Monitors
In a comparison study of source data review (SDV) methods, this new process demonstrates the value of using well-planned data visualization tools to provide better quality oversight versus remote eCRF review or onsite SDV.
Exploring the Role of the Regional Coordinator
How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains
FDA’s John Whyte Delves Deeper into Patient Centricity
November 30th 2016The FDA’s Dr. John Whyte recently shared his perspectives on patient centricity at eyeforpharma’s Patient Centered Clinical Trials conference. He continues the discussion by exploring the definition of patient centricity and issues that not only the FDA, but also the industry is facing.
Putting Our Shoulders to the Wheel: Thoughts on Data Sharing
November 30th 2016Data sharing in biomedical research has recently attracted widespread attention from physicians, scientists and stakeholders alike. DCRIs Dr. Eric Peterson discusses the context, flaws and positives of how this initiative could be implemented and the effects it can have on the industry.
Design of Early-Stage Trials Can Bring Success in CNS Disorders
November 30th 2016Finding and implementing an appropriate design for early-stage clinical trials is critical to the future success of medicines for central nervous system (CNS) disorders, according to new analysis from the European Medicines Agency (EMA)
Little European Love on Show for Drug Research
November 29th 2016The latest official review of European health strategy has been released at the request of the European Commission in an attempt to address Europe’s healthcare challenges. Peter O’Donnell reports that the clinical trials community is likely to be disappointed at the report’s findings.