Hart Clinical Consultants (HCC) will assist business partners to provide unparalleled world-class support and service to ensure clinical and regulatory activities are conducted expertly in the conduct of global or US focused clinical trials

Hart Clinical Consultants is a full-service Contract / Clinical Research Organization  providing staff augmentation and  comprehensive study management services through all phases of clinical trial operations.  The team is expert operating under either 312 or 812 regulations managing studies from phase I (first in man) to phase IV (post-market).

Specific services offered:
* Comprehensive project management
* Comprehensive site management
* Comprehensive study monitoring
* Expert clinical specialist support for device training and proctoring innovative procedures
* Comprehensive data management
* Comprehensive safety management including medical monitoring and management of CEC and DSMB operations
* Comprehensive site payment process
* Comprehensive investigational device inventory management
* Technical writing services
* Agency BiMO inspection preparedness

For more information, visit www.hartclinicalconsultants.com


Clinical Trials

Health Care

Medical Devices

Hart Clinical Consultants

Jim Hart

Wendy Hart

Merrie Moorhead

Nelleke Yarbrough

Jan Cross

The Clinical Operations team at Hart Clinical Consultants oversees the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and optimizing study processes from phase I through phase IV. This team coordinates comprehensive project and site management, conducts thorough study monitoring, and supports device training and proctoring. They also manage data and safety, including medical monitoring, CEC, and DSMB operations, while handling site payments, investigational device inventory, and technical writing.

Clinical Operations

Clinical Operations

About

Team members