While speed and efficiency are vital aspects of any study start-up, approaching the process with only these goals in mind can create issues that can set you back and impact the overall success of your studies. Fortunately, evaluating some of the details underlying your start-up timelines can remove the potential for certain missteps. With these things in mind, here are five tips for improving your study start-up timelines:
A frequent question asked in our industry is: "How much should we pay investigators for their work on a clinical trial, and what methodology should be used?" While this question seems straightforward, it is quite complex. The amount and method by which you pay investigators can play a big role in the success, or lack thereof, of your research department.
One of the negative aspects of clinical trials is the possibility that a patient will suffer an injury or illness as a result of their study participation. As such, one of the most important pieces of a contract is the subject injury language. ‘Subject Injury’ is defined as an injury, illness, adverse event/reaction, or death caused by a study subject’s involvement in a clinical research study. Prior to the study, the research site and the study sponsor should come to an agreement on what exactly constitutes a Subject Injury, and who pays in the event of a Subject Injury.
A Clinical Trial Management System (CTMS) is a computer software system that manages data within a clinical trial. The system centralizes the administrative components of each study, including billing, reporting and tracking. Many research sites, institutions, sponsors, and CROs use these systems to monitor clinical trials. Below are 3 key benefits of implementing a CTMS.
With the advancement of medicine over the past several years, it is no surprise that clinical research has become more complex. In conjunction with these advancements, hospitals and health systems are making significant changes to their research operations.
National and Local Coverage Determinations (NCDs and LCDs) are two of the most important aspects of Medicare coverage. Both NCDs and LCDs are released by Centers for Medicare and Medicaid Services (CMS) to standardize Medicare coverage for certain medical tests and procedures. These determinations outline the conditions in which a service is considered to be covered by Medicare.
Much has been written about the changing clinical research landscape, and more importantly, the implications these changes are having on small, independent research sites. The first major change was the implementation of preferred site programs by many larger contract research organizations (CROs). The second, and more recent development, is the actual acquisition of research sites and site networks by CROs. Separate of both of these trends, is the premise that “big data” will give larger health systems a competitive advantage, allowing them to reestablish their dominance in Phase II and III research. Each of these themes are explored in greater detail below.
Developing a coverage analysis (CA) can be a very tricky task, especially for a novice analyst. Nonetheless, it is crucial to conduct CAs in order to ensure billing compliance. There are several important items that need to be considered while building a CA. This list is not meant to focus on every single one of these items, but to highlight a few important items that should be considered while building a CA.
In the early 1960’s, changes in federal regulations sparked a revolution in drug research and development, particularly in regard to clinical trial testing when Investigational New Drug designations (INDs) and New Drug Applications were implemented.
Then in 1965, Medicare, the national social insurance program, was established.