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Compliance In Focus
Posted by John Lehmann on Mon, Sep 9, 2013

CV Clinical Trials Require Compassion and Understanding

doctorPreviously, we have discussed the importance of choosing a Contract Research Organization (CRO) for your Cardiovascular (CV) clinical trial that possesses a strong therapeutic background, as well as a strong regulatory foundation. We also acknowledged CROs, in order to be successful with CV clinical trials, must have a powerful knowledge of CV clinical trials along with the know-how to manage the complexities of your trial. Finally, here we explain why the right company must have the ability to understand you and your specific clinical trial needs while always putting patients first.

A CRO should put patients first.

Regardless of the type of trial, the primary mission of any CRO should be to protect human subjects. During CV trials, protocols may be more challenging, and the data may be more complicated. In fact, there is a lot of scrutiny when it comes to CV device trials.

Investigational CV devices provide opportunities for treatment that may not have existed for certain patient populations, but despite that, participation in clinical trials is voluntary, and patients need to be given adequate time to make autonomous, informed decisions based on an accurate description of the risks and benefits of participating in the clinical trial. In addition, as new information becomes available that may impact that subject’s willingness to continue his or her participation, patients need to be informed. You will want to work with a company that understands the requirements, puts human subject protection at the forefront, and will work with the sites to ensure there is no compromising in this regard.

A CRO should understand you and your trial.

During your trial, the last thing you want is a company that will come in and apply a heavy-handed approach. Instead, you want a company that will take the time to listen to what is needed – both at the sponsor and the site level, and then work to build a rapport with the various study team members that will bring great value to the study team. Approaching sites with a teamwork-oriented attitude rather than a hierarchical punitive attitude will facilitate a positive study experience that serves to protect that important relationship between the sponsor and the sites. Your CRO should help you build upon and maintain the relationships you have worked so hard to develop. If your monitors are out in the field interacting with investigators on your behalf, you want to know they will not do anything to damage that relationship. Find a company that understands this important relationship and is committed to representing your company well.

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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