Blog
Online registration grows clinical trial participation
Recently, Cedars-Sinai “Research for Her” advanced its clinical research study participation registry matching women with research studies and clinical trials. The results included more participants and reduced registration time compared to paper based processes. “A...
Genetic profiling done for genomically matched trials
Enrollment barriers to secure patients for genomically matched trials still challenge the discovery for molecular cancer therapies; however , help may be on the way. Only a few patients who have gene alterations are selected to participate in genomically matched...
EMA revising pediatric wavier forms
Many companies are hesitant to perform clinical studies on children due to the risks and ethical issues that can arise. This is why the European Medicines Agency (EMA) is looking into revising and reforming the product class waivers to allow companies to test new...
New report done by EMA finds deficiencies in GCP’s
A recent report done by the European Medicines Agency (EMA) on good clinical procedures (GCP) found there were deficiencies around standard operation practices (SOPs). These deficiencies were found in monitoring, data management, and other documents for trials done in...
21st Century Cares Act gets passed by Congress
The 21st Century Cares Act was passed with an overwhelming majority on July 10th, 2015. This bill would increase the funding for both the NIH and FDA and instate a new framework for evaluating patience’s experience with drugs risks and benefits. Not only will the bill...