Hart Clinical Consultants
Hart Clinical Consultants (HCC), established in 2011, is a leading Contract Research Organization (CRO) specializing in clinical trials for medical device, pharmaceutical, and diagnostic industries. With a focus on collaboration, excellence, and advancing new therapies, HCC offers comprehensive services across various therapeutic areas, including cardiovascular, neurovascular, diabetes, structural heart, surgical intervention, electrophysiology, and others. Led by founder and CEO Jim Hart, the company emphasizes high-quality results, regulatory compliance, patient safety, and innovative data management solutions. HCC is committed to being a trusted partner in clinical research, supporting clients from trial design to regulatory approval, and continuously improving through strategic acquisitions and expert leadership.
Industries
Nr. of Employees
medium (51-250)
Hart Clinical Consultants
Deland, Florida, United States, North America
Services
Operational management of clinical studies including project management, site oversight, monitoring and vendor coordination.
On-site clinical support including enrollment specialists, case proctoring and product/procedure training at clinical sites.
Clinical data management services including database build and validation, data cleaning, and coding workflows.
Safety surveillance and reporting services including adverse event review and coordination with independent safety committees.
Quality system implementation, site and vendor audits, and risk management to ensure compliance and continuous improvement.
Regulatory strategy and support for submissions and agency interactions across US and international jurisdictions.
Operational management of clinical studies including project management, site oversight, monitoring and vendor coordination.
On-site clinical support including enrollment specialists, case proctoring and product/procedure training at clinical sites.
Clinical data management services including database build and validation, data cleaning, and coding workflows.
Safety surveillance and reporting services including adverse event review and coordination with independent safety committees.
Quality system implementation, site and vendor audits, and risk management to ensure compliance and continuous improvement.
Regulatory strategy and support for submissions and agency interactions across US and international jurisdictions.
Expertise Areas
- Clinical trial management
- Clinical data management and CDMS
- Biostatistics and statistical analysis
- Safety management and pharmacovigilance
Key Technologies
- Clinical data management systems (CDMS)
- Custom clinical database development and validation
- Biostatistical analysis methods
- MedDRA coding
News & Updates
HCC has acquired LeCDMS, a leader in Data Management services, to expand its capabilities and offerings in clinical research.
Jason Krzeszak has joined HCC as Executive VP of Operations, bringing 20 years of industry experience.
HCC has acquired LeCDMS, a leader in Data Management services, to expand its capabilities and offerings in clinical research.
Jason Krzeszak has joined HCC as Executive VP of Operations, bringing 20 years of industry experience.