Five Questions Every Research Organization Should Ask Before Adopting a Centralized Clinical Trials Office

By David Russell, CRCP—Director of Site Strategy, PFS Clinical

In my years working in the industry, I’ve learned firsthand that no two research organizations are alike. For that reason, it’s impossible to find a one-size-fits-all model for a centralized clinical trials office (CTO). I’ve had the opportunity to support many organizations as they’ve moved toward a centralized CTO, and it’s always clear that the success of the venture requires that you take the time to evaluate strengths and opportunities for growth before you create a plan. Over time, I’ve developed a few key questions that can help research institutions identify existing skills and any initial hurdles that might inform and impact CTO creation. If your organization is looking to establish a centralized CTO, finding answers to the following questions can help create a blueprint for a plan that will enhance your individual processes.  

Here are five key questions every research organization should answer when considering moving toward a centralized CTO model:

Insurance Provisions in Clinical Research Contracts: Know the Terms 

Confused about insurance provisions for research contracts? We don’t blame you—insurance terms are complicated, even without the added complexity of figuring out how they apply to your research program. If you’ve found yourself swimming upstream through contracts full of insurance provisions you’re unsure of, let us help you out! In this article, you’ll find definitions of several common terms and policies, complete with discussions of how they interact with the services delivered by your organization during a clinical trial.

Latitude Updates: How Our New Project Tracking Software is Helping Clinical Research Programs Grow

Easy? Check. Transparent? Check. Real-time? Check.

That’s what clients should experience when placing service requests with us. Ideally, requesting services should be as easy as ordering a pizza, with nearly the level of transparency of one of those smartphone pizza delivery apps. While our services don’t translate directly to dinner delivery, offering a deliverable services tracking software that allows real-time, transparent communication between our research administration team and our client organizations felt important to us. This post will give you a bit of background information and update you on the progress of Latitude, our newly developed self-service client portal for ordering PFS Clinical’s services, tracking delivery, and benchmarking performance.

Don’t Leave Money on the Table: Ten Tips for Budgeting, Negotiating, and Collecting Clinical Trial Payments

While it may seem obvious that budget creation, negotiation, and payment collection are interconnected, institutions can be met with payment delays and unrecognized revenue if their strategies for these steps do not capture the points of connection from the start. Here are 10 tips that will help you build a holistic strategy for budgeting, negotiating, and collecting clinical trial payments.

Lessons Learned at the 2018 ExL Clinical Trial Billing and Research Compliance Conference

Blog Contributor Amanda Miller, Training Manager, Clinical Research Administration, PFS Clinical

Spending a few days of February in Orlando was a welcome experience for the Wisconsinites of PFS Clinical. Even so, the knowledge my colleagues and I gained through the conversations and panels we enjoyed at the ExL Clinical Trial Billing and Research Compliance Conference were more valuable than the fortunate change in weather conditions. It was an eventful conference, which resulted in a lot of important takeaways that have kept us thinking. For those of you unable to attend—and for attendees who, like me, are still mulling over what you learned-- here are some of the biggest clinical research billing and compliance lessons we learned from this event.

How to Avoid Common Gaps in Clinical Trial Revenue

While conducting clinical trials, staying on top of billing and expense coverage can feel never-ending, particularly if things do not easily reconcile. Luckily, from pre-study negotiations to post-study internal review, you can adopt practices at every step that will help ensure your site is not missing opportunities for reimbursement of research costs. This blog post explores some fairly simple practices your institution can use to avoid common gaps in financial management and ensure you won’t see a loss in revenue in clinical studies.

Is Your Clinical Research Revenue Cycle Too Slow?

Creating an efficient process for billing and identification of study-related procedures is a process in itself. Additionally, at large institutions where research is a small percentage of revenue, optimizing cash flow and compliance of the research revenue cycle may not be as big of a priority as it is for small institutions. Still, the absolute money value and risk in play can be substantial no matter your size. This blog details how partnerships between study teams and billing specialists can build accuracy and efficiency into your encounter identification and billing processes, mitigating risk and enhancing your revenue cycle.

Understanding the Differences Between Medicare’s “No Legal Obligation to Pay” Rule and the Secondary Payer Rule

The Medicare Secondary Payer rule (“MSP”) amended the Social Security Act (Section 1862(b)) to define circumstances when Medicare has an obligation to pay only after a primary payer has paid, or can reasonably be expected to pay for a billable item or service. The intention was to shift costs from government-payer coverage to private, third-party insurance, if an individual has dual coverage. MSP outlines how these dual benefits are coordinated, but how is this applied in the context of clinical research?

Five Tips for Improving Your Study Start-Up Timelines

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:

The Pros and Cons of Different PI Compensation Models

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. 

Medicare: What is it and How Does it Apply to Clinical Trials?

For the average person, understanding Medicare can be confusing and complicated. However, for people in the world of clinical research administration, understanding Medicare is a necessity in order to maintain billing compliance. Medicare rules are the foundation for clinical trial billing compliance, so understanding how Medicare can impact your research is crucial. To understand how Medicare impacts clinical trials, you must first understand what Medicare is, how it is broken up, and what makes a clinical trial qualified to receive Medicare coverage.

How can mobile health technologies benefit clinical trials?

The use of mobile health in clinical trials has been consistently growing for the last few years, and for good reason.mHealth has been gaining popularity in clinical trials because of its ability to gather general health data, as well as monitor real-time patient vital signs. mHealth technologies can benefit clinical trials in many ways by enhancing data collection, improving patient enrollment and engagement, and the lowering the cost of trials.

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.