We offer our clients full-service clinical research solutions, custom-designed for their specific research development program.

CLINICAL DEVELOPMENT PLANNING, PROTOCOL DESIGN, AND PROJECT MANAGEMENT

We develop comprehensive project management plans and standard and tailored tracking tools; implement rapid study startup with focus on subject recruitment, accrual, and protection; conduct simulation modeling for recruitment design and study rollout; and offer strategic site selection.

REGULATORY AFFAIRS

SSS employs a strategic focus on product development to ensure shortest path to approval. We develop and write regulatory documents and offer cloud-based eTMF and eSubmission platforms.

CLINICAL MONITORING AND SITE MANAGEMENT

SSS offers comprehensive clinical monitoring plans, and clinical site visits, reporting, and protocol-specific tool development.

BIOSTATISTICS AND DATA MANAGEMENT

We offer remote data capture and CRF design; real-time views of clinical trial forecasts, budgets, and data; data standardization using CDISC standards; analysis, modeling, and adaptive design; protocol development for meta-analysis of data sets; and data monitoring committee and interim analyses.

MEDICAL MONITORING AND SAFETY MANAGEMENT

SSS develops comprehensive safety management plans; determines subject eligibility; reviews medical coding, safety data, ECG, and lab data; and offers 24/7/365 SAE receipt, notification, reconciliation, and reporting.