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Study Management

Hoosier Cancer Research Network’s highly qualified staff provides comprehensive study management, from initial concept to final publication.

Project Management
Hoosier Cancer Research Network project managers coordinate and supervise clinical trials from concept to close out. They serve as the main point of contact with pharmaceutical companies, physicians, and research personnel. Project managers ensure that all project deliverables meet client expectations as well as Hoosier Cancer Research Network standards.

Safety
Hoosier Cancer Research Network complies with FDA reporting regulations and sponsor requirements. HCRN manages Serious Adverse Event (SAE) reporting, including communication with participating sites, sponsor investigator, and proper authorities; generating MedWatch Report Forms; and tracking all SAEs for each study. In addition, HCRN receives and processes all IND safety reports from pharmaceutical companies or protocol sponsors, and provides monthly safety updates to sites and project managers.

Data Services
Hoosier Cancer Research Network provides an electronic data capture system as well as EDC training and support to our member sites. HCRN also manages data queries, validation, and support for interim and final analysis of trial data. Our data team builds and supports databases for each trial.

Site Monitoring
Hoosier Cancer Research Network provides site verification and periodic monitoring visits to participating sites.

Publication Support
Hoosier Cancer Research Network provides support for publications and presentations for both interim and final analysis. HCRN studies have resulted in more than 300 publications.