Hart_MAP_Locations-r2

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

banner1

Experience managing all phases of clinical trials

banner3

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

shutterstock_73949041

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

banner4

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

image_pdfimage_print

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.

image_pdfimage_print

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
image_pdfimage_print

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
image_pdfimage_print

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 wide variety of EDC and CTMS systems

HCC on Twitter

image_pdfimage_print

Edwards SAPIEN 3 Ultra Transcatheter Valve for Severe Aortic Stenosis Cleared in Europe |
https://t.co/tpoZ9qgDmu

BioSig inks Pure EP first-in-human study deal with Texas Cardiac Arrhythmia Institute
https://t.co/SMZcdgkbao

Load More...