In 2013, the FDA released its final guidance on the use of Electronic Source Data in clinical investigations. In short, the premise of the guidance is that capturing clinical data digitally is better for all parties involved in the research activities. The industry...
The cost of pharmaceutical products is among the fastest growing components of health care costs today. A major contributing factor to those costs are the research and development departments aimed at discovering, developing, and commercializing new pharmaceutical...
The clinical trials industry has been slow to adopt technology, despite the abundance of new technologies that have emerged over the past decade and the rate of adoption by consumers. In the early 2000s, clinical trials began moving from paper and forms processing...
The statistics are overwhelming. Every successfully approved FDA treatment starts with the researching of thousands of potential treatments, can take anywhere from four to eight years of research and 1 to 2 years of FDA review, and cost upwards of $500 million to $1...
The 4th annual Clinical Research and Operations Worldwide Networking (CROWN) Congress was held from January 27 to 29, in Philadelphia, PA, and featured information and discussion on the latest approaches, strategies, tools, and technologies for optimizing clinical...
With the proliferation of inexpensive hosting solutions and the increasingly reliable availability, access to, and speed of the Internet, Clinical Data Management Systems (CDMS) have moved into the mainstream of the investigator market. What was once a dauntingly...
