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