The Holy Name Hospital Department of Clinical Research provides these high quality resources:
- Identification of GCP trained investigators
- Dedicated, fully-trained and experienced clinical research coordinators
- IRB submissions and correspondence (We use Central IRB/WIRB)
- Preparation and negotiation of itemized budgets
- Contract facilitation and development of master agreements
- Aggressive subject recruitment
- Recruiters and Coordinators use successful subject retention techniques
- Clinical, laboratory, and clerical ancillary support staff
- In-house quality assurance program and GCP auditing
- Performance tracking
- Comprehensive SOPs to ensure consistent and appropriate practices
- Data management and AE reporting support
- Protocol design and development
- Design Case Report Form (CRF) and Source document
- Assistance with strategy and proposal development for corporate-sponsored and investigator-initiated clinical trials
- Assistance with the development of large multicenter grant applications
- Physical space for conduct of trials
- Designated free parking for study patients, monitors, and sponsor representatives
- Provide GCP, HIPAA, Human Subject protection, transport of dangerous goods, budget & preparation, and other relevant training to the investigators, coordinators, and other study personnel.