One of the questions that is frequently asked in our industry is “How much should we pay investigators for their work on a clinical trial, and what methodology should be used?” The amount and method used to pay investigators may play a large part in the success, or lack thereof, of your site. The amounts paid to investigators are considered part of their overall annual compensation amount. This means that they are subject to Fair Market Value (FMV) guidelines. When determining amounts and methodology, a firm understanding of the laws governing investigator compensation is key to ensure compliance. This blog can help in determining methodologies and understanding laws that surround them. There are numerous approaches for paying principal investigators (PIs) and the three most popular models include: Research Salary, Percentage of Study Budget, and Hourly rate for work performed.
The benefits of a CTA Playbook are plenty, and its many uses make it a great tool for contract negotiators. Getting to use the playbook is a task in itself, so take the following implementation suggestions into consideration.
Centers for Medicare and Medicaid Services’(CMS) National Coverage Determination (NCD) 310.1 outlines the qualifying criteria to determine for which trials Medicare coverage “routine costs in clinical trials” applies. The first step in completing a coverage analysis is usually determining if the study meets these qualifying criteria. One of the common questions we hear is, what should we do if a trial does not meet the qualifying criteria?
It’s 2019?! 2018 flew by, and we wanted to share some highlights with our research community. PFS Clinical has seen significant growth and success thanks to our clients and partners. We remain committed to serving research organizations across the country and developing new ways to support research offices. Each year, we make it a goal to produce educational assets for the research community, and 2018 was not an exception. We published white papers, conducted four webinars, held two workshops, one of which had record attendance, placed seven speakers at four conferences, all to help drive research administration forward. In addition, we launched our services platform, Latitude, to create near-real time data to our clients. This blog post was created to share our successes, provide a quick review of our 2018 outcomes, and what we’re looking forward to in 2019.
It’s no secret that clinical trial agreement (CTA) negotiations can get complicated. To make the entire process more efficient, you should consider using a CTA negotiation playbook. When we refer to a playbook, we’re talking about a document which dissects the common provisions in a CTA. It can come in lots of different forms, which we’ll dive into a little later, but a playbook is basically an outline, a chart, or an annotated agreement which breaks down each CTA topic. This type of tool should provide guidance to you and your negotiators and be helpful whether you’re looking at a company’s template for the hundredth time or seeing one for the very first time.
It will likely come as no surprise to you if we open with this statement: insurance terms and provisions for research contracts are complicated. While a previous post established a basic definition of common clinical trial insurance terms and policy types, this article will identify a few helpful tips to determine the appropriate policy limits for your organization by exploring how your institution might assess risk for each study. Let’s get started!
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:
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.
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.
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.
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.
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.
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.
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?
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.
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.
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.
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.
Negotiating clinical trial budgets is often a lengthy back-and-forth process between the institution and sponsor/CRO. Consequently, this process can greatly delay study start-up. Here are five tips for more effective and efficient budget negotiations: