Benefits of a Clinical Trial Management System

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.  

HIPAA: Reflecting on the Past and Preparing for the Future

When the Health Insurance Portability and Accountability Act (HIPAA) went into effect over 10 years ago, it was met with great apprehension and concern from those in the healthcare industry. Today, it is one of the most important legal and ethical guidelines in the industry. How has HIPAA evolved since its inception? Let’s step back to examine a few key points in its development.

NCDs and LCDs 101

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.

Are Small, Independent Research Sites Going the Way of the Dinosaur?

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.

6 Things to Consider When Performing a Coverage Analysis

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.

NCD 310.1: Medicare's Clinical Trial Policy

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.