Applied Clinical Trials: Apr 30, 2015
Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.
Applied Clinical Trials: Apr 26, 2015
Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).
Applied Clinical Trials: Apr 26, 2015
In the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.
Applied Clinical Trials: Apr 21, 2015
TransCelerate recently announced a new initiative focused on eLabeling in clinical trials. The eLabels Initiative is expected to improve label usage for patients, streamline labeling approaches at sites and create opportunities to decrease timelines in the investigational supply chain resulting in cost efficiencies for sponsors.
Applied Clinical Trials: Apr 16, 2015
With the clinical trial industry’s focus on improving monitoring efficiency and leveraging a variety of risk-based monitoring (RbM) models, novel eClinical technologies are emerging to facilitate clinical trial monitoring productivity.
Applied Clinical Trials: Apr 13, 2015
While some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.
Applied Clinical Trials: Apr 12, 2015
Understanding the roles of eTMF, CTMS, and study startup solutions in the clinical trials process
Applied Clinical Trials: Apr 07, 2015
In a move designed to both tout the importance of precision and to improve the sponsor experience in conducting cardiac safety assessment, iCardiac Technologies announced a full risk-sharing program for Thorough QT studies.
Applied Clinical Trials: Mar 31, 2015
Organized by country and topic area, the site also allows users to compare the requirements of two countries side-by-side.
Applied Clinical Trials: Mar 30, 2015
“Never assume that something obvious is true,”