From a technical perspective, the beginning of the clinical research process often brings to mind images of scientists in the lab. But long before a drug or device company begins the arduous and uncertain journey to develop a new therapy, it is the patients and their stories that inspire
Representatives from ACI’s Data Standards Team attended the CDISC International Interchange in Chicago, IL, November 9-13, 2015. As a CDISC Registered Solutions Provider for over 10 years, ACI maintains comprehensive knowledge of CDISC Data Standards and the challenges sponsors typically face on the path to regulatory submission. With the
The New England Journal of Medicine today shared landmark results from the EMPA-REG OUTCOME trial. The study revealed a marked reduction in cardiovascular (CV) mortality and morbidity for high CV risk type 2 diabetes patients when taking empagliflozin (a sodium glucose cotransporter 2 inhibitor). Throughout the randomized, double-blind, placebo-controlled trial, all cardiovascular
Many of our pharmaceutical clients, both large and small, are regularly faced with the challenge of conducting multiple clinical trials to study various aspects of a particular drug or device on the path to commercialization. For example, one clinical trial might assess the safety and efficacy of a single
On November 8th, the president of the American Medical Association (AMA), Robert M. Wah, addressed the House of Delegates at the AMA Interim Meeting in Dallas, Texas. In his Star Wars-themed speech, Dr. Wah spoke about new diagnosis codes (the ICD-10), Medicare (and its Sustainable Growth Rate, SGR), Ebola,