Effectively Managing Clinical Trial Receivables

Clinical trial agreements are notorious for their complex and often confusing payment terms. Those terms make it difficult for research institutions to accurately track how much is owed to them by sponsors/CROs and if they have been paid correctly for a study. Effectively managing your receivables can change the way your institution does business, and it has many benefits.

NCI Accreditation 101

The National Cancer Institute (NCI) Cancer Centers Program, which is responsible accrediting high performance cancer centers, is a leading voice in the nation’s cancer research effort. There are currently sixty-nine NCI-Designated Cancer Centers that form the nexus of the NCI’s initiatives for studying and combatting cancer.  While there are many cancer centers in existence, becoming NCI-accredited is one of the most rigorous and prestigious designations in the country.

Budgeting for Clinical Trials 101

Developing an internal budget can be a complex process, but it’s important for many reasons. First, the internal budget allows the research office to see the actual cost to conduct a study. Additionally, the internal budget is often more detailed than the budget provided by the sponsor. Your internal budget might vary from other institutions due to specific processes, and it can be built in an excel document or directly into a CTMS. Developing an internal budget allows for additional comments and clarifications that may not be possible to add to the sponsor’s template. Lastly, an internal budget can be formatted to meet any specific internal needs. A good example of this might be including specific formulas to account for how much money should be allocated to the PI, the nurse or coordinator, or to cover various departmental fees.

Subject Injury Language: What You Need to Know

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.

Four Common Oversights of Investigator Initiated Trials

Within the past two years, investigator initiated trials (IITs) have seen a remarkable renewed interest. While research offices are doing their best to support these endeavors, the additional administrative responsibilities involved are often unfamiliar to research offices. Consequently, mistakes made during the initial development and start-up stages can cause compliance and financial ramifications. Here are four common mistakes to look out for when conducting an IIT study:

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.