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Our CRAs are located across the US, allowing for regional coverage of your project

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Experience managing all phases of clinical trials

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Extensive on-site monitoring experience using a variety of data collection processes

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Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

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Cath lab professionals with extensive proctoring experience…HCC works with you

MISSION: Hart Clinical Consultants (HCC) is a Functional Service Provider (FSP), expertly staffed, providing business partners with unparalleled world-class clinical and research support services through all trial phases.

Project Management

Experts in clinical trial execution:

  • Creation of regulatory strategy
  • Development of study protocol
  • Creation of study timeline
  • Creation of study budget
  • Creation of study support materials
  • Management of trial execution from initiation through close out and final report

Device Training / Case Proctoring

Experts in training medical & support staff:

  • Direct Cardiac Cath Lab experience
  • Direct Endovascular/Neurovascular Interventional Lab experience
  • Direct Cardio-Thoracic OR experience
  • Comprehensive device / procedure training
  • Comprehensive cadaver / animal lab training

Monitoring

Experts in on-site/remote monitoring activity:

  • Compliance with FDA GCP regulations
  • Compliance with ICH guidelines
  • Adherence to quality plans and systems
  • Experience with a wide variety of EDC and CTMS systems
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