Contract negotiations are just that—negotiations. Some back and forth is to be expected when building an equitable set of contract terms, but at what point do terms become non-negotiable? Here are five examples of some the major deal-breakers in contract negotiations:
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 site.
Clinical research coordinators are an incredibly important part of the clinical research process. Their role has continued to evolve in recent years, as clinical trials have continued to grow in complexity.
For many research sites, navigating the clinical trial landscape can be very intimidating. Site networks offer many benefits to research sites, but here are five main reasons why every clinical research site should consider joining a site network:
Stem Cells Edited to Fight Arthritis – Read More >
Researchers at the Washington University School of Medicine and Shriners Hospitals for Children have rewired stem cells from mice in an effort to reduce inflammation caused by arthritis and other conditions. These stem cells are developed into cartilage cells that produce a biologic anti-inflammatory drug that may be able to replace arthritic cartilage, protecting joints and other tissues from further damage.
Site selection is a complex process composed of multiple factors on which research sites are evaluated. It may seem as if your success is solely in the hands of sponsors and CROs, but there are several things you can do to help your site get selected on more studies. Here are three tips from the site selection and business development team at PharmaSeek:
Advertising plays an important role when it comes to recruiting patients for clinical trials, but it’s often underutilized by sites or not used at all. Whether this is due to a lack of internal staffing or expertise, there is a lot of potential going untapped when sites bypass study advertising.
World’s Smallest Pacemaker Revealed – Read More >
The Micra Transcatheter Pacing System (TPS), a new pacemaker the size of a nickel, can now be implanted in patients with bradycardia to help pump enough blood through the body during physical activity. The tiny device is just 1/10th the size of a traditional pacemaker, and it is currently the only leadless pacemaker approved for use in the United States. The TPS is also unique in that it doesn’t require cardiac wires or a surgical pocket under the skin to deliver a pacing therapy.
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.
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.
Branding is extremely important when trying to establish a credible business. Whatever it is that you are selling - food, tools, beauty products, pet supplies, a type of service, etc. - your business needs a brand. Believe it or not, in addition to companies like Coca-Cola, McDonald’s, Starbucks, and Target, clinical research sites and health institutions must also have a solid brand behind them. Some people believe that a concrete brand is not necessary for the healthcare industry because the demand for healthcare will always be prevalent. The fact that the demand will always be around is true, but there is still competition in the healthcare industry, and standing out from the crowd is crucial to attract new patients.
Finding research sites that are capable and willing to conduct your clinical trials can be a burdensome task. Since 1995, Pharmaseek has partnered with both sponsors and CROs to identify clinical research sites for clinical trials in virtually every therapeutic area. What started as a group of twelve research sites has grown into a network of approximately 250 investigative research sites, the largest network of its kind. Research facilities in the PharmaSeek network range from small practices to large academic institutions.
A crucial component to having a successful clinical trial is enrolling participants, but not just any participants—the right ones. With already full plates, where do busy sites begin the process of patient recruitment advertising?
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.