Striving to defeat cancer and other illnesses, Fred Hutch researchers regularly conduct innovative infectious disease research and global clinical trials. These life-saving efforts require meticulous data management and adherence to international compliance standards.
Over the past 30 years SCHARP has conducted more than 250 HIV prevention and vaccine studies in domestic and international sites. SCHARP and its partner SDMCs are currently managing nearly 90 phase I – III clinical trials, with more than 40 actively enrolling or following participants. The studies are being conducted at over 400 clinical sites in more than 30 countries around the world.
Established in 1992 to support global HIV prevention research at Fred Hutch, we have since expanded to support additional therapeutic areas including oncology and other infectious diseases. SCHARP operates according to all national and international regulatory standards. Our team with over 190 clinical trials specialists are skilled in biostatistics, programming, IT data systems, quality assurance, project management and clinical and lab data management collected from multiple sources worldwide.
Advancing Scientific Breakthroughs
Researchers and statisticians at SCHARP played an instrumental role in a landmark discovery that was quoted by Science as 2011’s scientific breakthrough of the year.
Results: early use of antiretroviral drugs reduces HIV transmission to uninfected heterosexual partners by 96 percent.
SCHARP frequently supports publishing critical study results in partnership with their clinical research collaborators worldwide. Learn more about SCHARP leadership and the high-impact learning environment that drives us.
Our Statistical and Data Management Services
SCHARP supports clinical researchers and administrators with high quality clinical and laboratory data management and statistical services.
Clinical Data Management
- Data collection system support and development
- CRF definition and development
- EDC programming
- Data management plan creation and maintenance
- Data quality monitoring and discrepancy resolution
- Clinical safety monitoring
- Adverse event and drug coding
- Site training and support
Laboratory Data Management
- 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
Programming and Information Technology Services
- Validated 21 CFR Part 11 compliant systems
- Software development
- IT system security, support and administration
- IT infrastructure development
- CDISC data standards
- Clinical trial report development
- Operational and statistical programming and reporting
- Data archiving
Statistics
- 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
Quality Assurance and Regulatory Compliance
- Quality Management System
- SOP creation and management
- Document Control
- Training records
- Event reporting and CAPAs
“We are motivated by the quest to improve global health, but we are also dedicated to building a mission driven organization of talented, engaged and supported employees and empowered teams, where people are eager to come to work.”
— Peter Guarino, SCHARP Executive Director
Major SCHARP Research Projects
SCHARP provides statistical support and data management services to researchers worldwide in the fight against HIV/AIDS, cancer, and other infectious diseases.
HIV Vaccine Trials Network (HVTN)
Funded by the National Institutes of Health, HVTN oversees worldwide clinical trials to test vaccines against HIV/AIDS. The network designs and conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.
HIV Prevention Trials Network (HPTN)
Founded in 2000, HPTN researches integrated strategies for HIV prevention, including antiretroviral drugs and behavioral interventions. The global network evaluates new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection.
Microbicide Trials Network (MTN)
Established in 2006, MTN conducts studies aimed at developing topical or oral antiviral medications to reduce transmission of HIV/AIDS. The network includes more than 25 clinical research sites in seven countries worldwide.
Vaccine Immunology Statistical Center (VISC)
VISC is a Bill & Melinda Gates Foundation-funded program that provides statistics support for the Foundation’s HIV vaccine development initiative, Collaboration for AIDS Vaccine Discovery (CAVD). VISC partners with SCHARP for management of lab data and other critical operational support.
Global Oncology
Nearly a quarter of the world’s cancers are caused by infectious diseases that are preventable or treatable. We address these cancers by focusing on the support of research, clinical care and training of cancer specialists, scientists and support staff in Uganda and other countries. Our mission is to reduce the burden of cancers around the world through improved diagnosis, better prevention strategies and optimized treatment plans.
