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In the world of oncology, clinical research is a major force in the advancement of treatments for different cancers. According to the National Cancer Institute, clinical research studies are crucial for physicians to find new ways to improve cancer treatments. It is critical to understand the role of clinical research in oncology, as it is central for discovering and improving cancer treatments for people all over the world.
Budget negotiations can become complex if a negotiator doesn’t come fully equipped. To expedite the process, every negotiator should have a plan in place prior to sending the first communication to their negotiation counterpart. This blog will detail useful strategies for effective and efficient budget negotiations.
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.