Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.
At the 2016 SCRS (Society for Clinical Research Sites) Global Site Summit, Christine Pierre, president of SCRS, shared the results of a survey conducted of site professionals from around the world. The survey is conducted every year, just prior to the summit, to gauge the opinion of site professionals on various issues and trends. If the results are any indication, there is still room for improvement in sponsor/site relationships.
Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.
In 2007 Synergy opened a Clinical Data Management Department with local, low-budget projects and decided to implement an open source EDC solution as a clinical data collection tool. This tool required installation and validation every time a new project was started. When the number of projects started to multiply, management quickly realized they had two options: expand their IT resources to support data management applications or outsource. They chose the second option so they had to find a cost-effective, pay-as-you-go, cloudbased EDC solution which would allow them to move their current EDC projects without interruption.
In 2005, Abbott sanctioned an executive-sponsored governance body to drive the development and implementation of enterprise-wide study build, data capture and trial management processes using a single electronic data capture (EDC) vendor for all clinical studies. The objective was to quickly move the lion’s share of studies to electronic capture means while maximizing site acceptance.
Today, EDC systems are widely adopted by life science companies and well established as a critical technology for conducting clinical research, especially for large multi-site trials.