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...
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...
NIH may be the next to join Apple and Google in using technology (i.e. smartphones) to help gather information for clinical trials. This new step for the NIH came under the White House’s Precision Medicine Initiative (PMI). President Obama hopes the PMI will “bring us...
According to a recent article by Senator Amy Klobuchar, the United States has always been the world leader when it comes to biomedical research and innovation. However, many other countries are starting to rapidly catch up, and the United States may need to put more...
The US Food and Drug Administration (FDA) has been looking into ways to test Electric Health Record (EHR)-to-Electric Data Capture (EDC) approach for clinical trials. The administration believes that this could open up new opportunities for clinical trials through...
