Blogs

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.
Sep 14, 2017
Applied Clinical Trials
Austin Speier, VP of Emerging Technologies at Precision for Medicine, recently spoke about mHealth regulatory pathways at PanAgora’s Mobile Innovations Summit, and will elaborate further in this Q&A interview.
Sep 13, 2017
Applied Clinical Trials
With the ever changing regulatory landscape, outsourcing non-core activities is a flexible approach to managing resources and remaining compliant with NCO requirements for the entire generic portfolio.
Sep 11, 2017
Applied Clinical Trials
George Clinical's Managing Director discusses the concern biopharma companies have with CFDA's slow drug and medical device approvals.
Sep 05, 2017
Applied Clinical Trials
This article outlines the EMA's response from a previous blog by Peter O'Donnell regarding the potential of Milan, Italy as the EMA relocation.
Aug 31, 2017
Applied Clinical Trials
What cannot have escaped the attention of any impartial observer is that Milan is one of the leading contenders to host the EMA and that Tajani and Rasi are both Italian. The EMA relocation is a hot topic without any bias towards Milan.
Aug 25, 2017
Applied Clinical Trials
The National Institutes of Health (NIH) focuses on developing strategies that will encourage further research to support safe and effective therapies for pregnant and lactating women.
native1_300x100
lorem ipsum