Hart Clinical Consultants is a specialized Functional Service Provider (FSP) that partners innovators of technical, novel medical devices with highly-skilled CRAs, expert in executing clinical trial operations and training medical and hospital support staff.
HCC’s team specializes in training on the proper prep and use of technical, novel medical devices and proctoring innovative medical procedures. Areas of expertise include cardiovascular, endovascular, neurovascular, pulmonary and diabetes medicine. Additionally, HCC’s staff is credentialed by the ACRP and/or SoCRA organizations, and are seasoned study/site managers/monitors.
The HCC Difference:
What differentiates HCC from a CRO is that our staff has either direct interventional cath lab or cardio-thoracic OR experience. This allows HCC to function extremely well in technical areas when carrying out clinical trial operations (monitoring) or conducting device training and/or proctoring procedures.
HCC’s staff has supported clinical trial operations for a variety of products and indications, including but not limited to:
- Therapeutic hypothermia in the setting of STEMI AMI
- Bare metal coronary stents for the treatment of native and by-pass graft coronary stenosis
- Drug-eluting coronary stents for the treatment of native stenosis
- Bare metal carotid stents for the treatment of native carotid stenosis
- Embolic protection devices for the use during carotid intervention procedures
- Variety of bare-metal and drug-eluting stents for the treatment of endovascular stenosis
- Vessel closure devices used to obtain hemostasis following coronary, carotid or endovascular intervention
- Embolic retrievers for the treatment of neurovascular thrombus in the setting of acute stroke
- Bioabsorbable scaffolds in intranasal anatomy for treatment of chronic obstructive sinusitis
- Flow generator, masks and algorithms utilized in the treatment of obstructive sleep apnea
HCC CRAs have experience and expertise managing a wide range of clinical trials, from pre-clinical (animal lab), phase I (first in human), to large pivotal randomized trials and post-market surveillance trials.
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