1. Research Support
- Experienced Investigators
- Protocol Consultation
- On-site investigational pharmacy
- Experienced, dedicated, study coordinators
2. Budget/Contract
- Staff experienced in creating and negotiating budgets and contracts
3. Quality Assurance
- Compliance with Food and Drug Administration (FDA) and Code of Federal Regulations (CFR) requirements
- On-site IRB with biweekly scheduled meetings
- Experienced regulatory affairs coordinator to prepare IRB submissions and maintain regulatory documents
- Standard Operating Procedures consistent with regulatory requirements
- Good Clinical Practice (GCP) trained staff with certification
- Centralized scheduling of meetings for site assessment, initiation, and study monitoring visits
- Study report preparation and submission
- Subject Identification and Recruitment
- Potential participant databases
4. Research Facilities
- Extensive clinical and academic research facilities
- Dedicated laboratory, monitor rooms, patient exam/treatment rooms and waiting areas
- Secure research drug storage and dispensing areas
- Phlebotomy and laboratory analysis services available
5. Data Management and Reports
- High quality clinical and research data
- Secure data storage environment
- Report and manuscript writing
