Clinical Trial Services
Site Management
Click here if you are interested in working with HCRI on potential studies.
The efficient management of study sites is fundamental to the success of a clinical trial. Knowing and monitoring the activities taking place at each site is crucial to having valid, credible data entered and analyzed. The site management team develops a strong working relationship with each site to ensure proper conduct of the trial in accordance with applicable laws and regulations.
The Site Management group is the vital link between the sponsor and the site. It provides full site support and monitoring from study start-up to close-out. Experienced in-house staff and contract monitors with expertise in therapy-specific services will manage each step of the project.
Site monitoring visits encompass a range of activities, including assessment of enrollment and continuing protocol adherence, review of all relevant source documents, reporting of previously unreported SAEs, and investigation and resolution of outstanding queries.
HCRI’s comprehensive site management services include:
- Investigator recruitment, including development of project-specific questionnaires
- Planning and coordination of investigator meetings
- Collection and continued review of site regulatory documents
- Development of informed consent template
- Development of study-specific tools
- Ensuring regulatory and protocol compliance by facilitating monitoring visits, including:
- Qualifying site assessments
- Initiation visits
- Interim monitoring visits
- Close-out visits
- 100% source documentation of trial data
- Negotiation and administration of site grants and site payments
