Nov 23, 2015
The industry is experiencing a paradigm shift from pharmacovigilance rooted in case processing and compliance reporting to a safety program built around benefit-risk management.
Nov 18, 2015
Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.
Nov 17, 2015
Large pharma companies have fallen “below legal and ethical standards” for making public information from the relevant clinical trials, according to a report from Bioethics International.
Nov 16, 2015
TransCelerate’s Risk Assessment and Categorization Tool (RACT) has exhibited usefulness with study teams and has guided organizations, such as Cancer Research UK (CRUK) to adopt their own RBM questionnaires
Nov 12, 2015
(MCC) is conducting an industry survey about risk-based monitoring (RBM) practices in order to assess how RBM approaches have grown and evolved over the last two years.
Nov 11, 2015
Applied Clinical Trials
CBI’s conference proves RBM was just the beginning. Now companies are honing in on the risks and mitigations related to clinical trial data reporting.
Nov 03, 2015
Applied Clinical Trials
The ability to have access to real-time information through leveraging technology combined with a strategic business perspective allows companies to implement a true quality management system.
Oct 28, 2015
Applied Clinical Trials
Applied Clinical Trials is collaborating with the Clinical Endpoints Adjudication Group to conduct an industry survey to evaluate the impact of technology on endpoint adjudication processes.
Oct 26, 2015
Applied Clinical Trials
Clinical Ink, an eSource solutions provider, offered Applied Clinical Trials raw data from its Site Impact Survey for analysis. This article will delve into this data to uncover breakthrough trends regarding the utilization of eSource on workload reduction at study sites.
Oct 21, 2015
Applied Clinical Trials
CDER has thrown down the gauntlet to industry on eSource, and now has their work cut out for them on next steps.
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