Pillars of Service

Project Management

At Hart Clinical Consultants, our team of CRAs is made up of experts in the planning and execution of clinical trial operations, helping study sponsors achieve trial milestones and goals within established budget and timeline projections. HCC’s Project Managers function as the lynchpin between study sponsor senior management and study site investigators and personnel, ensuring compliance of clinical trial operations to ICH guidance and FDA GCP regulations.

Device Training / Case Proctoring

HCC’s staff of RNs and BSNs are highly skilled in a variety of technical therapeutic areas including cardiovascular, endovascular and neurovascular intervention. We train investigators and site support personnel on the proper prep, set-up and use of technical novel medical devices according to established Instruction for Use (IFU), and proctor innovative procedures ensuring procedural and device success while minimizing complications.

Monitoring / Data Management

At HCC, we ensure compliance to FDA GCP regulations and adhere to ICH guidance standards in the conduct of clinical trials. Our clinical consultants also possess extensive on-site and remote monitoring experience including risk-based monitoring plans utilizing a variety of data collection processes, such as paper CRFs and electronic databases. HCC consistently receives feedback from sponsor and site personnel that we are knowledgeable, accurate, detailed-oriented, courteous, and achieve study goals and milestones.

Specific Services Offered:

  • Training physician and medical staff on proper prep, set-up and use of novel medical devices
  • Conducting in-depth hands-on training and proctoring innovative procedures
  • Creation of study teams for the execution of clinical trial operations
  • Performing project management activities including management of study start-up timelines, budgets and tracking regulatory submissions and approvals
  • Managing support staff, contract personnel (CRAs) and core-lab personnel
  • Creating and negotiating study and site budgets
  • Conducting all aspects of clinical trial operations including: pre-qualification visits, site initiation visits, and interim/close-out monitoring visits
  • Conducting data management function and data review
  • Creating study protocol, informed consent template and CRFs including writing database completion guidelines
  • Assisting with identification of project goals and determination of study objectives and clinical endpoints
  • Implementing Quality System Program including creating and writing standard operating processes and procedures
  • Assisting with study recruitment and developing strategies to achieve enrollment milestones
  • Facilitating safety committee meetings including preparation of adverse event packets and documentation
  • Ensuring and documenting on-going and productive communication between study site and sponsor personnel
  • Assisting with site or sponsor inspections from regulatory agencies including the FDA
  • Facilitating/conducting investigator meetings and advisory board meetings
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