Clinical Trial Services
Project Management
Each trial is assigned a dedicated lead who serves as the primary point of contact and creates and manages the project team from all functional areas.
Every project at HCRI is managed for success. Effective project management is a major key to realizing a sponsor’s objectives, including study details, timelines, and important regulatory considerations.
HCRI has a history of superb clinical trial management. Each trial is assigned a dedicated lead who serves as the primary point-of-contact to spearhead and coordinate the activities of all functional areas. The project manager works closely with the sponsor to ensure that the trial is effectively driven to completion.
HCRI understands that each trial is conducted within a unique and a dynamic environment. Each Project Manager completes formal training and demonstrates fluency in the operational requirements of multi-centered, complex clinical trials.
The project manager monitors and coordinates all aspects of a clinical trial, ensuring that relevant information is promptly relayed to sponsors. Project teams provide input into protocol and CRF design, report trial status on a periodic basis, and coordinate tangential services, including core laboratories. Project managers also work to meet timelines and business milestones.
The HCRI project management offering includes:
HCRI has a history of superb clinical trial management. Each trial is assigned a dedicated lead who serves as the primary point-of-contact to spearhead and coordinate the activities of all functional areas. The project manager works closely with the sponsor to ensure that the trial is effectively driven to completion.
HCRI understands that each trial is conducted within a unique and a dynamic environment. Each Project Manager completes formal training and demonstrates fluency in the operational requirements of multi-centered, complex clinical trials.
The project manager monitors and coordinates all aspects of a clinical trial, ensuring that relevant information is promptly relayed to sponsors. Project teams provide input into protocol and CRF design, report trial status on a periodic basis, and coordinate tangential services, including core laboratories. Project managers also work to meet timelines and business milestones.
The HCRI project management offering includes:
- Delivery of a completed project scope of work
- Oversight of all study-related activities
- Facilitation of communication between the sponsor and team members
- Development and management of study timelines and milestones, budgets, and deliverables
- Review of study deliverables, including the CRFs, CRF completion guidelines, DSMB and CEC charters, and all reports
- Creation of meeting minutes, scheduling and coordination of DSMB meetings, and other administrative study needs
- Coordination of attendance at investigators' meetings
- Coordination of ad hoc requests, including statistical analyses for presentations or publications and regulatory body responses
