In our last post, we revealed one of the most important aspects of choosing a Contract Research Organization (CRO) for your Cardiovascular (CV) clinical trial. But your research cannot end there. Several other elements will impact your trial, and you need to be well aware of them in order to successfully pass Food and Drug Administration (FDA) or other bureau inspections. Read on to find out how CRO employees and capabilities can affect your CV clinical trial and how to ensure best results.
First, choose a company where employees have a powerful knowledge of CV trials.
Your trial deserves a higher level of expertise than can come from a company that participates in CV trials every now and then, or a company that does the majority of its work on pharmaceutical trials; it deserves a company that has a proven track record of managing the complexities of CV trials every day. Consistency requires a depth of knowledge and experience that comes with companies that work with both large medical device manufacturers running multi-national studies to single center investigator-initiated IDEs.
If possible, take a look at the professional background of employees. Ideally, many of those who will be working on your trial will have a CV background. You may be able to find nurses who have 15 to 20 years of CV experience. This helps individuals to understand the therapeutic area and the scrutiny the FDA puts on cardio vascular device manufacturers. It also creates an understanding of the typical hospital charts that will be presented during the trial and many of the challenges that will arise.
If applicable, look for a company with a medical device focus, which includes knowledge of 21 CFR 812 regulations, a core competency. A company that has previously worked with many of the sites in the CV arena and knows the thought leaders in the field, as well as their research coordinators can have real benefits, too. Finally, ensure the company you choose understands the technology, the clinical setting it is used in, and its application. Preferably, a company will have vast experience in various CV technologies, including implantable devices, imaging studies, and IVD studies focused on the various stages of CV disease. Look for a company that has experience with at least a majority of these CV trials:
- Endovascular grafts
- Balloon-expandable stents
- Drug-eluting stents (coronary, iliac, renal, femoral)
- Vena cava filter
- IVDs for diagnosing MI
- IVUS imaging
CV trials are five, sometimes 10, years long. They often involve lifesaving, significant risk devices, and there are regulations that need to be followed, including 21CFR 11, 50, 54, 56, and 812. Consequently, a lot of long-term data is collected, which can be challenging. Due to the long length of time, subjects may not return for follow-up visits, sites may have staff turnover or inconsistencies within their study teams, and the energy level of a trial may wane as the trial progresses, among other challenges. Adapting to the cycles within a long trial may require a company to rapidly identify the problem and set its problem solving engine into motion, perhaps conducting additional training, supporting a new research coordinator, visiting the sites more often to reduce the possibility of complacency, or any other number of interventions. The bottom line? Find a company that understands what sponsors need in order to run a successful clinical trial from beginning to end.
Next, choose a company that has the capacity to monitor your trial.
Your trial is unique. You can’t just rely on anyone to monitor your trial, and the size of some research companies is certainly worrisome. Choose a company that is big enough to accommodate your work, yet small enough to remain flexible. In the end, you want a company that can handle the complexities of your trial and make logical suggestions for optimizing protocol implementation. Look for that “all hands on deck” mentality, so you know your trial will be handled professionally, regardless of what situations present themselves.
So how will you know a CRO has the capacity to work on your trial? To ensure the company has the expertise and ability to successfully manage your trial, you will want to make sure the company has worked with both large global corporations and small start-up organizations—and also has the ability to integrate well with the existing team. Monitors should be able to integrate seamlessly into your existing study team, follow your procedures or their own, depending on your preference, and go above and beyond to exceed your expectations.
The people behind the CRO can make all the difference when it comes to your CV clinical trial’s success. Don’t hesitate to learn more by contacting John Lehmann at 440.801.1540 or via e-mail at email@example.com.