40+ years of experience
Our Services
Efficient
Timelines for Activation
Rapid Protocol Development
- Dedicated development staff facilitate final protocol throughout various levels of scientific, statistical, and operational review
Rapid Contracting
- HCRN negotiates study funding agreement with lead institutions and companies providing study support
- HCRN expedites site contracting by executing work orders under a master agreement with member institutions
Rapid Site Activation
- HCRN maintains baseline general regulatory documents (e.g., CVs, medical licenses, laboratory certifications, etc.)
- Dedicated regulatory staff coordinate documentation for timely site-specific IRB submission
- Dedicated project managers coordinate web-based training, SIVs, and comprehensive study management
Accurate and Relevant Data
Systemized
Robust, customizable web-based electronic data capture (EDC) system.
Standardized
Several layers of data validation ensure high-quality and consistent data.
Verified
Dedicated on-site study monitors provide source data verification.
Customized
Protocol-specific data exports.
Rapid Accrual
- Feasibility assessments identify optimal sites from our network of more than 100 academic and community sites
- Dedicated project management team focused on study engagement to promote timely accrual
- IRB-approved communications for web, social media, and advocacy groups
Regulatory Compliance
Reduced administrative burden
HCRN maintains a high level of regulatory compliance while reducing administrative burden through efficiencies gained by working within our network.
Submission and maintenance
HCRN supports submission and maintenance of FDA required documentation, including IND application, annual reports, amendments, and MedWatch reports.
Centralized SAE processing
HCRN provides centralized SAE processing that includes reporting, as applicable, to funders and all applicable authorities.
Data and Safety Monitoring Coordination
HCRN coordinates ongoing data and safety oversight throughout the life of the study.
Biorepository and Correlative Services
Hoosier Cancer Research Network recognizes the importance of correlating clinical and laboratory data with the goal of identifying factors that are associated with response and/or toxicity to treatment. Samples collected from consented patients participating in HCRN studies are shipped to our biorepository for storage and management.
