The ROC under Dr Stone’s direction designs, executes, and standardizes end-to-end study operations—from development and validation of screening and diagnostic assays, protocol development and biospecimen collection to cell isolations, study-specific processing, testing, data linkage, and long-term storage through the VRI Biorepository. This infrastructure supports multicenter clinical and observational studies, enabling high-quality, reproducible data generation across diverse research programs.

Cell isolations & study-specific processing

• PBMC isolation: Ficoll/CPT from whole blood or leukapheresis with defined time/temperature windows and QC.
• Cryopreservation & recovery: Controlled-rate freezing, LN₂ vapor storage, post-thaw viability/yield checks.
• Subset enrichment: Magnetic selection (e.g., CD4⁺, CD8⁺, CD14⁺, B cells) with pre/post purity assessment; optional aliquoting for multi-omics.
• Study-specific workflows: Plasma/serum separation, buffy coat/granulocyte preps, whole-blood RNA stabilization (PAXgene/Tempus), live-cell steps (e.g., stimulation, intracellular staining)

Biospecimen lifecycle oversight

• On-site collection oversight
  • Phlebotomy and processing SOPs, order-of-draw, pre-analytical variables, deviation capture.
• Central receipt, accessioning, and triage
  • Chain-of-custody, condition checks, reconciliation to manifests, triage to testing vs. storage.

Study planning & start-up

• Operational protocol development
  • Convert study aims into SOPs, manuals, kit lists, processing/ship windows, hold times, and test menus.
  • Define inclusion/exclusion and visit schedules from a biospecimen/assay standpoint.
• Feasibility & pilot runs
  • Pre-launch pilots to confirm draw volumes, tube types, stability, and assay performance.
• Site selection & activation
  • Qualify sites for collection capability, cold-chain access, and data capture.
  • Deliver initiation trainings; maintain version-controlled documents.

Kit manufacturing & logistics

• Collection kit build
  • Barcoded tubes, shippers, RTC/2–8 °C/−20 °C/−80 °C materials, IFUs, return labels.
• Cold-chain shipping coordination
• Supply forecasting & resupply
  • Rolling forecasts and supply tied to enrollment

Assay development & validation

• Fit-for-purpose validation
• Analytical sensitivity/specificity, linearity, precision, matrix effects studies.
• Proficiency & lot-to-lot controls
• In-house proficiency panels; external QC programs
• Documentation
• Validation plans/reports, change controls, and versioned SOPs aligned to sponsor/regulatory expectations.

Central laboratory testing management (VRI)

• Serology testing and panels
• NAT / molecular detection and sequencing
• Ultrasensitive assays
  • Single-copy HIV RNA (replicate-based platforms and validated manual methods) for residual viremia; p24 where suited.
• Bridging & method transfer
  • Cross-platform comparisons, dilution schemes, LoD/LoQ verification to support multi-site harmonization.