Services

The SF Coordinating Center provides a full-range of services to support multi-center studies. Services range from study design and identification of clinical centers to data analysis and publication. The SF Coordinating Center may provide a complete set of design, implementation, and analysis services, or any subset of available services. The SF Coordinating Center subcontracts for site management, laboratory services, repository services, and other specialized services.

We have large and unique databases from our longitudinal studies that are available for hypothesis generation, sample size estimation, and clinical trial or cohort study planning. These ensure productive and efficient resource utilization. We also have data collection form prototypes for all aspects of measurement including diet, cognitive function, medications, co-existing medical conditions, quality of life, health status, and functional outcomes.

The SF Coordinating Center has its own state-of-the-art, real-time, web-based data management system. This validated system allows data entry from multiple sources (e.g., web, fax, scanner). It produces real-time reports that are web-based and customized to the needs of individual studies.

Sponsors may contract with the SF Coordinating Center for any or all of the following services:

Study Design

• Choose appropriate study design and measurements
• Estimate sample size and power
• Use data from large community-based studies for study planning
• Develop protocols
• Develop operations manuals
• Design, pretest and validate instruments

Clinical Site Selection and Management

• Select appropriate clinical centers from established network in the U.S., Canada, or overseas
• Design and test recruitment and follow-up procedures
• Select and contract with core labs and reading centers
• Site and staff training/certification in study procedures including interviews, measurements, data management, and good clinical practice
• Direct clinical measure quality control

Data Collection and Management

• Design, produce, and test data forms
• Implement data management system
• Collect and clean study-wide data
• Generate reports and direct quality control
• Provide analysis data sets
• Archive data
• Select samples for nested studies
• Assess vertebral fractures by quantitative and semi-quantitative methods
• Adjudicate events (heart, cancer, stroke, fracture outcomes)

Data Analysis and Publications

• Develop randomization schemes
• Develop interim and final analysis plans
• Resolve statistical methods issues
• Perform interim and final analyses
• Produce manuscripts and presentations and coordinate study-wide analysis and publications involving multiple investigators

Study Coordination

• Develop systems and guidelines for governance of the study
• Establish and maintain communications systems
• Monitor study-wide progress
• Coordinate study-specific committees
• Provide or subcontract core technical services (central laboratories and reading centers)
• Coordinate shipments of specimens
• Design and produce newsletters, brochures, and recruitment materials
• Maintain comprehensive study-wide archive
• Organize and coordinate data and safety monitoring board activities
• Coordinate publications involving multiple investigators