Clinical Trial Project Management

For sponsors who need to leverage clinical trial outsourcing to extend their core competencies, The Harte Group uses either traditional Clinical Research Organization (CRO) models or supplements your teams with functional and specialty service providers.

We assign a seasoned industry executive as your point of contact.  The project manager works with you to select and qualify the appropriate CROs, discussing strategy and coordination between parties to ensure complete service level and quality agreements.  The project manager will establish timelines for deliverables across all vendors, collect and review all plans, and ensure that the CROs adhere to the sponsor’s and their own work practices.

The Harte Group can support the selection or oversight of:

  • Quality Assurance and Quality Control
  • Site Selection and Support
  • Patient Recruitment and Retention
  • Clinical Trial Management Services
  • Clinical Trial Project Management
  • Clinical Monitoring
  • Medical Safety
  • Data Management
  • Biostatistics
  • Medical Writing
  • Clinical Supplies
  • Service Level and Quality Agreements (CROs)
  • Contract and Budget Negotiations (Sites)
  • Grant and Vendor Payments
  • Regulatory Affairs
  • Clinical Technologies Support