Drug Safety Manager
In 2009, President Obama passed the American Recovery and Reinvestment Act, and from that came the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH began the push for healthcare organizations to convert from paper to electronic medical records. The Centers for Medicare and Medicaid Services began to enforce HITECH by offering incentive […]
The completion of the human genome project and advances in genetic engineering have paved the way for clinical trials involving human gene transfer, colloquially known as gene therapy research, to enter the mainstream. Gene therapy research involves the deliberate transfer of engineered genetic material to humans, with the goal of compensating for genetic mutations, conferring […]
Innovation and technology are driving efficiency and performance in clinical research by changing the way data are captured, monitored, analyzed, and reported. Mobile and Internet-connected medical devices generate large volumes of data in an environment where data science, data discovery, and visual analytical tools are empowering clinical researchers and study teams to improve trial management, […]
It’s time to get serious. Serious about rock-solid standards. Serious about clear career paths. Serious about raising the bar to a new level of professionalism in the clinical research workforce. Frankly, we see too many variables in the clinical trials industry, starting with training and development for the people who roll up their sleeves and […]
An institutional review board (IRB) is an independent body that reviews proposed human subjects research in order to ensure that proposed activities are in compliance with applicable regulations and the ethical principles described in the Belmont Report. The use of the term “institutional” in IRB is derived from the reality that most clinical research studies […]