Challenge:

As our expertise in the design and execution of stent trials became well-known, we were approached by a host of companies with a wide range of first-in-class novel interventional devices. These organizations also sought trial design and operational expertise. The majority of these technologies emerged from start-up enterprises who sought us out in order to complement their expertise in engineering and science with our knowledge of trial design, statistics and trial operations and how to present this entire package to FDA. As such, we often provided support to these companies over the course of many years and numerous studies, which helped to shape their future and success. These devices included vascular closure, embolic protection, heart failure, PFO closure, numerous techniques for addressing restenosis, carotid stents and peripheral arterial devices.

Solution:

Throughout all of these experiences, The Baim Institute has taken a consistent approach. We provide a diverse group of experts, including Faculty and operational experts, who can understand an organization’s goals and help to put the right elements in place. This begins with selecting the most appropriate trial design and continues with implementing the study in a high quality fashion.

Outcome:

This is a unique combination of skills that few other AROs possess and which has served us well over the previous 23 years. The primary evidence that we are able to provide is the many FDA approvals that resulted from the trials in which we were involved.

In 2005, Dr. Baim summarized our achievements in this regard as follows: “Over the last decade, the HCRI team has continually set the standard for the design, conduct, and analysis of innovative clinical trials across the entire spectrum of interventional cardiology. Their ability to ‘deliver the goods’ in this critical space – that can determine the life or death of a product or an entire company – is simply unmatched.”