Clinical Sciences Core (C) : Services


Biostatistical Services

  • Study design
  • Power calculation/sample size
  • Data analysis plan
  • Data analysis
  • Abstract, manuscript assistance and collaboration

Clinical Services

  • Study design/protocol development
  • Subject recruitment, screen, consenting
  • Clinical assessment
  • Clinical research pharmacy
  • Facility/equipment access

Detailed Descriptions

  • Both straightforward and more complex sample size and power calculation
  • Generation of statistical hypotheses, development of analytic plans and final analysis
  • Statistical analysis of datasets for abstracts and manuscripts

Study Subject services

  • For pilot studies/CFAR development studies, subject identification, recruitment, consent and supported intervention capability
  • HIV testing (rapid test)
  • Provision of research pharmacy services for interventional studies

Clinical Specimen services

  • Identification/collection of fresh clinical samples (whole blood, plasma, sera) for well characterized HIV subject population, including HIV viremic and aviremic
  • Identification/collection of fresh clinical samples (whole blood, plasma, sera) for well characterized HIV negative controls
  • Access to stored samples (plasma, sera, PBMCs) from well characterized longitudinal cohort, limited to study design need of longitudinal sampling
  • Limited mucosal samples ( rectal, cervicovaginal) from clinically well characterized HIV subjects and HIV negative controls
  • Specimens provided with linked available clinical dataset (demographics, CD4 cell counts, RNA levels, intervention type and antiretroviral regimens)

Study development and consultative services

  • Assistance with clinical study design and development
  • Assistance with investigator initiated studies, pilot studies, CFAR Developmental study with subject identification and recruitment, research nursing assistance, phlebotomy, limited tissue collection, data management and research pharmacy services
  • Access to state-of-the-art clinical research facility for pilot studies, CFAR Developmental awards, NIH studies and industry studies
  • Access to expertise in the development and implementation of vaccine trials
  • IRB submission guidance