Statistical Center for HIV/AIDS Research and Prevention (SCHARP)

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 25 years SCHARP has earned a reputation as a world-class statistical and data management center dedicated to improving global health and eliminating devastating diseases. Operating within Fred Hutch’s Biostatistics, Bioinformatics and Epidemiology Program, our staff of over 150 biostatisticians, programmers, data experts, and clinical trials specialists manage clinical and laboratory data and support statistical design and analysis of preclinical through phase 4 clinical trials. SCHARP has supported more than 200 clinical trials and epidemiologic studies including several high-profile international clinical trials.

Established in 1992 to support global HIV prevention research at Fred Hutch, we have since expanded to support additional therapeutic areas including cancer and other infectious diseases. SCHARP operates according to all national and international regulatory standards. Our team is skilled in programming, biostatistics, IT data systems, quality assurance, project management and clinical and lab data management collected from multiple sources from multiple sites worldwide.

Advancing Scientific Breakthroughs

SCHARP World Map

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.

The results: early use of antiretroviral drugs reduces HIV transmission to uninfected heterosexual partners by 96 percent.

More than 1,700 couples with different HIV status from nine countries on four continents participated in the study.

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

Our team supports clinical researchers and administrators with high quality clinical and laboratory data management and statistical services.

Clinical Data Management

  • CRF definition & development
  • CDISC data standards 
  • EDC programming
  • Data management plan creation and maintenance
  • Data quality monitoring and discrepancy resolution
  • Clinical safety monitoring
  • Adverse event coding

Laboratory Data Management

  • Specimen monitoring and tracking
  • Quality assurance and processing of lab data
  • Reconciliation of lab data with clinical data
  • Assay data processing

Statistics

  • 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
  • Validated 21 CFR Part 11 compliant systems

“We are motivated by the quest to improve global health, but we are also dedicated to building an organization of smart, empowered teams, where people are eager to come to work.”

— Peter Guarino, SCHARP Director

Major SCHARP Research Projects

SCHARP provides statistical support and data management services to researchers worldwide in the fight against cancer, HIV/AIDS 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.

Contact SCHARP

Piilani Pang, Administrative Manager