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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.