Blogs

Oct 13, 2017
Applied Clinical Trials
FDA advisory committee made up of patients comes together to improve clinical trials and product development through better study design and greater participation.
Oct 10, 2017
Applied Clinical Trials
Most physicians and many specialists have limited understanding of clinical trial data and research findings presented in prescription drug promotional materials for professional audiences.
Oct 06, 2017
Applied Clinical Trials
The Duke Margolis Center for Health Policy (DMCHP) recently collaborated with the FDA to release an mHealth action plan entitled "Mobilizing mHealth Innovation for Real-World Evidence Generation."
Oct 05, 2017
Applied Clinical Trials
This article will dive into the details of FDA’s movement in mHealth, analyze FDA’s approach, and assess how this movement impacts the use of mHealth in clinical trial settings.
Sep 26, 2017
Applied Clinical Trials
Gaps in the good manufacturing practice controls on medicines for clinical trials are targeted in new rules from the EU.
Sep 26, 2017
Applied Clinical Trials
The EMA isn't mincing its words about the challenge it faces with the relocation that will be forced on it by Brexit. It has been stated that "the future of public health in Europe is at stake" and this decision will make or break it.
Sep 26, 2017
Applied Clinical Trials
There is a critical need to rethink standards of evidence and of the reliability of information used to make regulatory decisions. According to the FDA, this involves placing greater reliance on data from sources outside traditional clinical studies and because of these new tools for collecting the data, the FDA needs to adapt as well.
Sep 21, 2017
Applied Clinical Trials
Hugo Stephenson examines his longing for the past with the advances of today's technology in this blog focused around sites.
Sep 20, 2017
Applied Clinical Trials
Since the emergence of the independent IRB sector, sponsors have found that regulatory and ethical review by a single IRB yields important benefits with respect to efficiency, high quality, and consistency in human research protections.
Sep 14, 2017
Applied Clinical Trials
Jeff Lee had the opportunity to be a moderator at the Mobile in Clinical Trials event where he sat down with mobile experts within the pharmaceutical industry. The session allowed for new observations in regards to the value that these mobile technologies have within clinical trials.
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