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 managemnet of CEC and DSMB operations * Comprhensive site payment process * Comprehensive investigational device inventory management * Technical writing services * Agency BiMO inspection preparedness For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com