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Compliance In Focus
Posted by John Lehmann on Fri, Aug 16, 2013

Top Tip for Choosing a CRO for Your CV Clinical Trial

business meetingChoosing the right Contract Research Organization (CRO) for your Cardiovascular (CV) clinical trial is imperative for so many reasons, but a strong foundation and a robust background are the building blocks for various other elements. If you are searching for a CRO for your upcoming CV Clinical trial, read on to find out how a company’s background can affect your trial.

But first, let’s take a look at what sets CV clinical trials apart from other clinical trials.

Clinical trials conducted in the CV arena are challenging, first and foremost, due to the variety of underlying disease states and conditions that affect a majority of potential trial participants. In addition to participants coming into the study with multiple co-morbidities, CV studies themselves can be quite complex. From the selection of meaningful endpoints and measurement techniques, to complex randomization schemes, the differences between CV trials from other trial types become obvious.

Layer these initial complexities with protocol designs that may incorporate a control group, retrospective and prospective elements, long-term follow-up, or imaging requirements to support the safety and efficacy of new technology, and a sponsor can easily see the scope of the study becoming much more difficult to manage. These difficulties can result in opportunities for inconsistency, inferior quality and non-compliance by sites struggling with a very complex protocol.

So what is the No. 1 rule of thumb when choosing a CRO for your CV clinical trial?

Choose a company with a strong regulatory foundation and robust therapeutic background.

Regulation-focused compliance should be at the foundation of your CRO partner. Being aware of the requirements the Food and Drug Administration (FDA) has put in place to ensure high quality clinical research data and protection of human subjects is critical in a CRO partner. While that sounds obvious, it unfortunately is the exception, not the rule, as evidenced by the number of warning letters issued year after year. By working in a regulatory framework, non-compliances can be identified readily, and corrective actions can be put in place to secure compliance. Clinical trials, by nature, are complex. You don’t have unlimited time for a CRO to get comfortable. You will want to find a company that, with minimal ramp up, can hit the ground running due to its background and knowledge. To be successful in any clinical trial, a company should be well-versed in the disease process, as well as the regulatory framework within which researchers developing these novel treatments must work. This happens over time by covering such therapeutic areas as thoracic and abdominal aortic aneurysms, peripheral vascular disease, coronary artery disease, heart failure, ischemic cardiomyopathy, and arrhythmias, among others.

Look for a company that has experience in a vast majority of these therapeutic trials:

  • Abdominal aortic, aortoiliac, or iliac aneurysms
  • Thoracic aneurysms
  • Coronary disease
  • Renal artery disease
  • Superficial femoral artery disease
  • Heart failure
  • Ischemic cardiomyopathy
  • Aortic dissection
  • Fibrillation (both atrial and ventricular)

This expansive experience is important in order to develop the creative problem solving and critical thinking skills needed to navigate adversities the client or sponsor will face.

For more information on how you can help prepare your CV trials for success, please contact John Lehmann at 440.801.1540 or via e-mail at jlehmann@imarcresearch.com.

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Topics: Contract Research Organization, cardiovascular clinical trial, Clinical Research

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