SCHARP services include:
The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) is part of the Biostatistics, Bioinformatics and Epidemiology (BBE) research program at Fred Hutch Cancer Center and is housed under the Vaccine and Infectious Disease Division (VIDD).
SCHARP is a full-service statistical and data management center (SDMC). We provide these services for our partners and customers:
- Study design
- Sample size calculations and randomization
- Clinical and lab data management
- Site training
- Clinical safety monitoring
- Clinical coding
- Statistical analysis and reporting
- Data dissemination and archiving
These core SDMC services are supported by teams working on quality assurance, IT systems, programming and business operation services.
Data Analytics
Data analytics provides statistical support throughout the entire lifecycle of clinical studies – from design and planning through analysis and exploration. This includes processing and analyzing complex data sets to generate insights, identify trends and support data-driven decision-making in partnership with our collaborating researchers and institutions.
- Statistical study design
- Sample size and power calculations
- Statistical analysis plan creation and maintenance
- Randomization planning and operations
- Data and safety monitoring reports and support
- Endpoint adjudication support
- Interim study analysis
- Final statistical analysis and study reports
- Manuscript and abstract analysis, writing, and support
- IND reports
- Data dissemination
- Data collection system support and development through EDC programming
- Case Report Form (CRF) data collection tool definition and development
- Data management plan creation and maintenance
- Data quality monitoring and discrepancy resolution
- Site training and support
- Clinical coding of event, medical history and drug data to industry standard dictionaries
- Clinical safety monitoring
- Development of protocol safety strategy, safety reports and safety management plans
- Facilitating regular safety data and sponsoring medical monitor reviews
- Managing study safety pauses and halting criteria
- Monitoring serious, expedited and special interest adverse events
- Safety data reconciliation
- Collection and management of site local reference ranges for evaluation of participant safety
- Data collection and management of lab assay data used for immunogenicity, adherence, pharmacokinetics and diagnostics
- New experimental assay expectations and data format development
- Specimen monitoring and tracking
- Lab data transfer support from local and central labs
- Quality assurance and processing of lab data
- Reconciliation of lab data with clinical data
- Assay data processing
Quality Assurance and Regulatory Compliance
The Quality Assurance department oversees the Quality Management System (QMS), which is a comprehensive system documenting processes, procedures and responsibilities to achieve quality objectives for the program. This ensures that our products and services align with industry quality standards, maintenance of data integrity and compliance with regulatory requirements.
- Standard Operating Procedure (SOP) document control program
- Staff training program
- Event and CAPA program
- Internal audit program
- Vendor/supplier management program
- System validation and system change management program
- Trial Master File (TMF) program
- Host for client audits and regulatory inspections
- Compliance with 21 CFR Part 11 and computer systems validation
- System development and integration
- IT system security, support and administration
- IT infrastructure engineering
- CDISC data standards
- Enterprise data management and reporting
- Strategic Planning
- Program and Portfolio Management
- Administrative Services
- Learning and Development
- Project Management
- Process Improvement
- Product Management